Radiation Therapy for Ventricular Tachycardia

Overseen By Fereshteh Talebi, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Pregnancy, Prior chest radiation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 1 week

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should have failed or be intolerant to certain heart medications, which might imply changes to your medication routine. It's best to discuss this with the trial coordinators.

What data supports the effectiveness of the treatment Radiation Therapy for Ventricular Tachycardia?

Research on intraoperative radiation therapy (IORT) shows it can improve local control and survival rates in various cancers by delivering high doses of radiation directly to the tumor bed during surgery. This suggests that similar targeted radiation approaches might be effective for other conditions, like ventricular tachycardia, by precisely targeting affected areas while sparing healthy tissue. ^{1 2 3 4 5}

Is radiation therapy generally safe for humans?

Radiation therapy techniques like intensity-modulated radiotherapy (IMRT) and image-guided radiotherapy (IGRT) have been studied for safety, showing some risks of side effects such as gastrointestinal and genitourinary issues, but these are relatively low. Safety considerations are important and have been a focus of ongoing research to ensure patient safety in various treatments. ^{6 7 8 9 10}

How is radiation therapy different from other treatments for ventricular tachycardia?

Radiation therapy, specifically stereotactic body radiotherapy (SBRT), is a non-invasive treatment that uses precise radiation to target areas of the heart causing ventricular tachycardia, unlike traditional treatments like antiarrhythmic drugs and catheter ablation, which can have limited effectiveness and potential side effects. ^{11 12 13 14 15}

What is the purpose of this trial?

This is a research study that aims to understand if giving a lower dose of treatment all at once is as effective and safe as dividing it into three smaller doses for patients with a heart condition called refractory ventricular tachycardia (VT). These patients have not exhibited positive responses to conventional medications or procedures. This study aims to explore whether an alternative approach could yield more beneficial outcomes.

Research Team

Silvia Formenti, M.D.

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

This trial is for patients with a heart condition called refractory ventricular tachycardia, which causes rapid heartbeat. These patients should not have responded well to standard treatments. Specific eligibility criteria are not provided, but typically include factors like age, overall health, and the severity of VT.

Inclusion Criteria

I have a type of heart muscle disease.

My VT has not improved with medication or a procedure, or I can't have the procedure.

Ability to understand study protocol and to write informed consent

Exclusion Criteria

I am under 18 years old.

Pregnancy

I have had radiation therapy to my chest before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive stereotactic body radiotherapy (SBRT) in either a single fraction or three consecutive fractions, depending on the randomized treatment arm

1 week

3 visits (in-person) for three fractions or 1 visit (in-person) for single fraction

Follow-up

Participants are monitored for safety and effectiveness after treatment, with primary safety assessment at 6 weeks post-treatment

6 weeks

1 visit (in-person)

Long-term Follow-up

Participants are monitored for long-term treatment side effects and overall survival

24 months

Treatment Details

Interventions

• Radiation Therapy

Trial Overview The study is testing radiation therapy as a treatment for VT. It compares two approaches: delivering one large dose at once versus splitting it into three smaller doses over time. The goal is to determine which method is more effective and safer for controlling this heart condition.

Participant Groups

Group I: 8Gy Radiation Dose for 3 fractions (Arm 2 Group 3) Experimental Treatment 1 Intervention

Arm 2: Group 3 (3 participants) - will receive a dose of 8 Gy ("Gray", a measurement of radiation) given over 3 days (Days 1, 2 and 3). (Total radiation dose = 24Gy)

Group II: 20 Gy Radiation Dose (Arm 1 Group 1) Experimental Treatment 1 Intervention

Arm 1: Group 1 (3 participants) - will receive a dose of 20 Gy ("Gray", a measurement of radiation) in a single study intervention (one study intervention day)

Group III: 15 Gy Radiation Dose (Arm 1 Group 2) Experimental Treatment 1 Intervention

Arm 1: Group 2 (3 participants) - will receive a dose of 15 Gy in a single study intervention (one study intervention day)

Group IV: 12 Gy Radiation Dose for 3 fractions (Arm 2 Group 1) Experimental Treatment 1 Intervention

Arm 2: Group 1 (3 participants) - will receive a dose of 12 Gy ("Gray", a measurement of radiation) given over 3 days (Days 1, 2 and 3). (Total radiation dose = 36Gy)

Group V: 10 Gy Radiation Dose for 3 fractions (Arm 2 Group 2) Experimental Treatment 1 Intervention

Arm 2: Group 2 (3 participants) - will receive a dose of 10 Gy ("Gray", a measurement of radiation) given over 3 days (Days 1, 2 and 3). (Total radiation dose = 30Gy)

Group VI: 10 Gy Radiation Dose (Arm 1 Group 3) Experimental Treatment 1 Intervention

Arm 1: Group 3 (3 participants) - will receive a dose of 10 Gy in a single study intervention (one study intervention day)

Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in United States as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Canada as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Japan as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in China as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Switzerland as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Findings from Research

Intraoperative Radiotherapy (IORT) using Photon Radiosurgery Systems (PRS) shows stable performance over time, with average output levels maintained at 99.12% during testing, indicating reliability for clinical use.

The dosimetric characteristics of the x-ray sources were consistent, with measurements falling within manufacturer tolerances, suggesting that all four systems can effectively deliver radiation therapy with similar performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional intercomparison of intraoperative radiotherapy equipment - Photon Radiosurgery System. Armoogum, KS., Parry, JM., Souliman, SK., et al.[2023]

Intraoperative radiation therapy (IORT) allows for targeted radiation delivery during surgery, which can enhance local control of tumors while minimizing damage to surrounding healthy tissues, making it particularly beneficial for patients with locally advanced or recurrent cancers.

The addition of IORT to standard treatment regimens has shown improved local control and survival rates in various cancers, including rectal cancer and breast cancer, suggesting its potential for broader application in clinical practice as new, cost-effective devices become available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative radiation therapy. Willett, CG., Czito, BG., Tyler, DS.[2022]

Intraoperative radiotherapy (IORT) was used in a study involving 1367 patients with 1400 tumors, showing a 5-year local recurrence rate of 5.98% for those receiving IORT only, which is comparable to other IORT studies but higher than standard whole breast radiation therapy (WBRT).

IORT offers benefits such as convenience and low complication rates, making it a viable option for patients meeting specific criteria, although the addition of WBRT was found to significantly reduce the risk of local recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recurrence and Survival Rates for 1400 Early Breast Tumors Treated with Intraoperative Radiation Therapy (IORT). Silverstein, MJ., Epstein, MS., Chen, P., et al.[2022]

Intraoperative radiation therapy (IORT) was assessed in 188 cancer patients, showing it to be a feasible and safe treatment option, with a 30-day postoperative mortality rate of only 3.2%.

While IORT was associated with a 28.7% rate of significant complications (grades III-IV), it was primarily used in conjunction with major surgeries and hyperthermic intraperitoneal chemotherapy, indicating its role in a comprehensive treatment strategy for various cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Intraoperative Radiation Therapy (IORT) in Multimodality Management of Cancer Patients: a Single Institution Experience. Elashwah, A., Alsuhaibani, A., Alzahrani, A., et al.[2023]

Intraoperative radiotherapy (IORT) effectively delivers a single dose of radiation directly to the tumor bed during lumpectomy, minimizing exposure to surrounding healthy tissues.

The TARGIT A and ELIOT trials support the use of IORT for post-menopausal women with low to intermediate grade, lymph node negative, invasive ductal carcinoma, aligning with international guidelines for accelerated partial breast radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative radiotherapy in breast conserving surgery. Holmes, DR.[2022]

In a study involving 42 cervical cancer patients, combining image-guided radiation therapy (IGRT) with high-dose-rate intracavitary brachytherapy (ICBT) improved the dose distribution to the tumor while reducing exposure to surrounding healthy tissues, such as the bladder and rectum.

The results showed that while the target dose to the high-risk clinical target volume (HRCTV) was similar between the combined treatment and optimized ICBT alone, the combined approach significantly increased the dose to intermediate-risk areas and decreased the dose to critical organs, suggesting a safer and more effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image guided radiation therapy boost in combination with high-dose-rate intracavitary brachytherapy for the treatment of cervical cancer. Wang, X., Li, J., Wang, P., et al.[2022]

In a study of 421 patients undergoing salvage radiotherapy (SRT) after prostate surgery, the use of advanced techniques like intensity-modulated radiotherapy (IMRT) and image-guided radiotherapy (IGRT) significantly reduced the incidence of late gastrointestinal (GI) toxicities to 4.8%.

However, increasing the radiation dose to 68 Gy or more was linked to a higher risk of genitourinary (GU) toxicities, indicating that while advanced techniques can help minimize some side effects, higher doses may still pose risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of advanced radiotherapy techniques and dose intensification on toxicity of salvage radiotherapy after radical prostatectomy. Tomita, N., Uchiyama, K., Mizuno, T., et al.[2021]

Image-guided radiation therapy (IGRT) has evolved significantly and is now widely used in routine clinical practice, emphasizing the importance of quality and patient safety in its application across various treatment techniques and anatomical sites.

The American Society for Radiation Oncology recommends a comprehensive quality-assurance program and an interdisciplinary team approach to ensure IGRT is performed safely and effectively, highlighting the need for ongoing updates to practice guidelines as technology advances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality and Safety Considerations in Image Guided Radiation Therapy: An ASTRO Safety White Paper Update. Qi, XS., Albuquerque, K., Bailey, S., et al.[2023]

In a study of 58 patients receiving high-dose radiation therapy for prostate cancer, using gold markers for image-guided radiation therapy (IGRT) reduced residual positioning errors, particularly in the vertical direction.

Despite the reduction in positioning errors with gold markers, the overall differences in dose distributions were moderate, suggesting that daily megavoltage CT (MVCT) alone could be a sufficient and valid alternative for IGRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric implications of inter- and intrafractional prostate positioning errors during tomotherapy : Comparison of gold marker-based registrations with native MVCT. Wust, P., Joswig, M., Graf, R., et al.[2022]

Image-guided radiotherapy (IGRT) can lead to significant additional radiation exposure for patients, with kV-CBCT delivering a median dose of around 30 mGy to the pelvis, while 2D-kV imaging provides the lowest dose at less than 1 mGy per image pair.

Optimizing imaging protocols can substantially reduce radiation doses, potentially decreasing exposure by up to a factor of 10, highlighting the importance of tailored imaging strategies based on patient anatomy and treatment goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monte Carlo-based software for 3D personalized dose calculations in image-guided radiotherapy. Le Deroff, C., Berger, L., Bellec, J., et al.[2022]

The study assessed the feasibility of using stereotactic body radiation therapy (SBRT) for treating ventricular tachycardia (VT) in one patient, showing that robust optimization techniques can significantly reduce radiation exposure to healthy heart tissues.

Using robust optimization, photon therapy reduced the average dose to the heart by about 25%, while proton therapy further decreased the dose to both the heart and left lung, highlighting the potential for safer treatment options for VT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton or photon radiosurgery for cardiac ablation of ventricular tachycardia? Breath and ECG gated robust optimization. Widesott, L., Dionisi, F., Fracchiolla, F., et al.[2021]

Stereotactic body radiotherapy (SBRT) is being explored as a non-invasive treatment option for ventricular tachycardia (VT) caused by myocardial scarring, which is traditionally managed with antiarrhythmic drugs and catheter ablation that have limited effectiveness and potential side effects.

This review discusses the principles and early results from trials and case series that suggest SBRT may offer a promising alternative for patients with VT that does not respond to standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Radiotherapy for the Management of Refractory Ventricular Tachycardia: Promise and Future Directions. Jumeau, R., Ozsahin, M., Schwitter, J., et al.[2020]

In a study of 10 advanced heart failure patients treated with stereotactic body radiation therapy (SBRT), there was a significant 69% reduction in the total duration of ventricular tachycardia (VT) detected by implantable cardioverter-defibrillators (ICDs) after treatment.

SBRT also led to a 68% reduction in the number of ICD shocks and a 48% decrease in antitachycardia pacing sequences, indicating that this noninvasive treatment can effectively reduce the burden of VT in patients who are refractory to standard therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical experience of stereotactic body radiation for refractory ventricular tachycardia in advanced heart failure patients. Lloyd, MS., Wight, J., Schneider, F., et al.[2021]

Cardiac stereotactic body radiotherapy (SBRT) has shown promising safety and effectiveness in treating refractory ventricular tachycardia (VT), with a significant reduction in VT burden of 98% at 6 months and 99% at 12 months after treatment in a study of 14 patients.

Despite some recurrence of VT in 33% of patients, SBRT demonstrated a favorable safety profile with no changes in ventricular function and a trend towards reduced amiodarone use, indicating its potential as a noninvasive treatment option for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-Year Outcomes Following Stereotactic Body Radiotherapy for Refractory Ventricular Tachycardia. Arkles, J., Markman, T., Trevillian, R., et al.[2023]

The STRA-MI-VT trial aims to evaluate the safety and efficacy of stereotactic body radiotherapy (SBRT) as a treatment for recurrent ventricular tachycardia (VT) in 15 patients with structural heart disease who are not candidates for catheter ablation.

If successful, SBRT could provide a less invasive alternative to traditional VT treatments, potentially improving patients' quality of life and survival rates over a follow-up period of up to 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

STRA-MI-VT (STereotactic RadioAblation by Multimodal Imaging for Ventricular Tachycardia): rationale and design of an Italian experimental prospective study. Carbucicchio, C., Jereczek-Fossa, BA., Andreini, D., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Functional intercomparison of intraoperative radiotherapy equipment - Photon Radiosurgery System. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Intraoperative radiation therapy. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Recurrence and Survival Rates for 1400 Early Breast Tumors Treated with Intraoperative Radiation Therapy (IORT). [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The Use of Intraoperative Radiation Therapy (IORT) in Multimodality Management of Cancer Patients: a Single Institution Experience. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Intraoperative radiotherapy in breast conserving surgery. [2022]

6. Poland pubmed.ncbi.nlm.nih.gov

Image guided radiation therapy boost in combination with high-dose-rate intracavitary brachytherapy for the treatment of cervical cancer. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Impact of advanced radiotherapy techniques and dose intensification on toxicity of salvage radiotherapy after radical prostatectomy. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Quality and Safety Considerations in Image Guided Radiation Therapy: An ASTRO Safety White Paper Update. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

Dosimetric implications of inter- and intrafractional prostate positioning errors during tomotherapy : Comparison of gold marker-based registrations with native MVCT. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Monte Carlo-based software for 3D personalized dose calculations in image-guided radiotherapy. [2022]

11. Italy pubmed.ncbi.nlm.nih.gov

Proton or photon radiosurgery for cardiac ablation of ventricular tachycardia? Breath and ECG gated robust optimization. [2021]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Stereotactic Radiotherapy for the Management of Refractory Ventricular Tachycardia: Promise and Future Directions. [2020]

13. United States pubmed.ncbi.nlm.nih.gov

Clinical experience of stereotactic body radiation for refractory ventricular tachycardia in advanced heart failure patients. [2021]

14. United States pubmed.ncbi.nlm.nih.gov

One-Year Outcomes Following Stereotactic Body Radiotherapy for Refractory Ventricular Tachycardia. [2023]

15. Netherlands pubmed.ncbi.nlm.nih.gov

STRA-MI-VT (STereotactic RadioAblation by Multimodal Imaging for Ventricular Tachycardia): rationale and design of an Italian experimental prospective study. [2022]