IORT + CT-Guided Brachytherapy for Breast Cancer

Recruiting at 2 trial locations

Overseen By Steve Fowler

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Shayna Showalter, MD

Disqualifiers: Male, Pregnant, BRCA mutation, others

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

Compensation: Varies

Number of Visits: 1

Duration: Immediate (during surgery)

358 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate an investigational way to provide radiation therapy to treat early-stage breast cancer at the time of surgery.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are undergoing initial medical treatment to reduce tumor size, you may not be eligible for this trial.

What data supports the effectiveness of the treatment IORT with CT-Guided HDR Brachytherapy for breast cancer?

Research shows that CT-guided high-dose-rate brachytherapy (a type of internal radiation) is effective in treating other cancers like cervical cancer and lymph node metastases, suggesting it could be beneficial for breast cancer as well. Additionally, intraoperative radiotherapy (IORT) has been studied as a boost in breast cancer treatment, indicating potential effectiveness when combined with other therapies. ^{1 2 3 4 5}

Is CT-guided HDR brachytherapy generally safe for humans?

CT-guided high-dose-rate (HDR) brachytherapy has been studied for various cancers, including lung and secondary malignancies, and is generally considered safe. Some minor complications like pain and fever have been reported, and major complications are rare. ^{5 6 7 8 9}

How is the IORT + CT-Guided HDR Brachytherapy treatment for breast cancer different from other treatments?

This treatment is unique because it combines intraoperative radiation therapy (IORT) with CT-guided high-dose-rate (HDR) brachytherapy, allowing for precise, customized radiation delivery during surgery, which is not possible with traditional methods that lack image guidance. ^{10 11 12 13 14}

Research Team

Shayna L. Showalter

Principal Investigator

University of Virginia

Eligibility Criteria

This trial is for women over 45 with early-stage breast cancer where the tumor is no larger than 3 cm. They must be planning surgery to conserve their breast or remove the whole breast. It's not for those with spread to lymph nodes, prior treatment to shrink the tumor, men, pregnant women, those with implants before radiotherapy, multiple tumors in one breast, skin/chest wall-involved cancer, previous same-side breast cancer or known BRCA mutation.

Inclusion Criteria

I chose a lumpectomy or radiation for my early-stage breast cancer.

I am 45 years old or older.

My tumor is 3 cm or smaller.

Exclusion Criteria

Patient with breast implants (does not include patients having implants AFTER intra-operative radiotherapy).

I have multiple cancer sites in the same breast.

I have a known BRCA gene mutation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single-fraction intraoperative radiation therapy (IORT) with CT-guided HDR brachytherapy at the time of breast-conserving surgery

Immediate (during surgery)

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with efforts to follow patients until death

24 months

Treatment Details

Interventions

• IORT with CT-Guided HDR Brachytherapy

Trial Overview The study tests a new method of delivering radiation therapy called IORT with CT-Guided HDR Brachytherapy during surgery for early-stage breast cancer. The goal is to see if this approach effectively treats cancer at the time of operation.

Participant Groups

Group I: IORT with CT-Guided HDR Brachytherapy Experimental Treatment 1 Intervention

Patients will receive IORT with CT-guided HDR brachytherapy at the time of breast surgery.

Who Is Running the Clinical Trial?

Shayna Showalter, MD

Lead Sponsor

Trials

3

Recruited

470+

Findings from Research

In a study of 23 patients with recurrent cervical cancer, image-guided high-dose rate interstitial brachytherapy (HDR-ISBT) showed a complete response rate of 56.5% and promising post-relapse survival rates, indicating its efficacy as a reirradiation treatment.

While HDR-ISBT is feasible and offers a good chance of survival, 39.1% of patients experienced significant late toxicities, including grade 3 or 4 complications, highlighting the need for careful patient selection and monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image-guided interstitial brachytherapy for recurrent cervical cancer after radiotherapy: A single institution experience. Ren, X., Fu, Y., Liu, Z., et al.[2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

CT-image-based conformal brachytherapy of breast cancer. The significance of semi-3-D and 3-D treatment planning. [2019]

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

An early report on outcomes from computed tomographic-based high-dose-rate brachytherapy for locally advanced cervix cancer: A single institution experience. [2016]

3. England pubmed.ncbi.nlm.nih.gov

Percutaneous ablation of lymph node metastases using CT-guided high-dose-rate brachytherapy. [2021]

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

Intraoperative Radiotherapy as a Tumour-Bed Boost Combined with Whole Breast Irradiation Versus Conventional Radiotherapy in Patients with Early-Stage Breast Cancer: A Systematic Review and Meta-analysis. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Image-guided interstitial brachytherapy for recurrent cervical cancer after radiotherapy: A single institution experience. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

[Percutaneous CT-guided high-dose brachytherapy (CT-HDRBT) ablation of primary and metastatic lung tumors in nonsurgical candidates]. [2016]

7. Germany pubmed.ncbi.nlm.nih.gov

CT-guided interstitial brachytherapy in the local treatment of extrahepatic, extrapulmonary secondary malignancies. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Randomised Phase II Feasibility Trial of Image-guided External Beam Radiotherapy With or Without High Dose Rate Brachytherapy Boost in Men with Intermediate-risk Prostate Cancer (CCTG PR15/ NCT01982786). [2019]

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

Computed Tomography-Guided Interstitial High-Dose-Rate Brachytherapy in Combination With Regional Positive Lymph Node Intensity-Modulated Radiation Therapy in Locally Advanced Peripheral Non-Small Cell Lung Cancer: A Phase 1 Clinical Trial. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

CT-guided iodine-125 brachytherapy as salvage therapy for local-regional recurrent breast cancer. [2023]

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

Novel Form of Breast Intraoperative Radiation Therapy with CT-Guided High-Dose-Rate Brachytherapy: Interim Results of a Prospective Phase II Clinical Trial. [2023]

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

A Novel Form of Breast Intraoperative Radiation Therapy With CT-Guided High-Dose-Rate Brachytherapy: Results of a Prospective Phase 1 Clinical Trial. [2018]

13. Australia pubmed.ncbi.nlm.nih.gov

Utility of CT imaging in a novel form of high-dose-rate intraoperative breast radiation therapy. [2019]

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

Risk analysis of electronic intraoperative radiation therapy for breast cancer. [2019]