HyperSight Imaging for Cancer

Overseen By Sean Davidson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Varian, a Siemens Healthineers Company

Disqualifiers: Pregnancy, Vulnerable populations

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

46 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a prospective, single-arm, single-site study designed to generate data describing the image quality and applicability/useability of a high-performance, on-couch CBCT imaging technology (HyperSight) in patients receiving radiation treatment for cancer on a C-arm linear accelerator (TrueBeam).

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment HyperSight, Varian HyperSight for cancer?

Imaging, like MRI, has been shown to improve survival outcomes in cancer care by helping detect cancer early and assess treatment responses, which can guide more effective treatment decisions. ^{1 2 3 4 5}

Is HyperSight Imaging generally safe for humans?

The research articles provided do not contain specific safety data for HyperSight Imaging or its related names. Therefore, no relevant safety information is available from these sources. ^{6 7 8 9 10}

Eligibility Criteria

This trial is for individuals with lung, abdominal, head and neck, or pelvic cancers who are undergoing radiation treatment. Participants must be able to receive imaging on a specific machine (TrueBeam). The exact eligibility criteria aren't provided here.

Inclusion Criteria

My cancer originates from or affects areas like the head, neck, lungs, liver, and others.

I was chosen to undergo radiation therapy with a Varian TrueBeam system.

I was prescribed a specific radiation treatment plan of at least 20 Gy over 5 days.

Exclusion Criteria

Patient is pregnant or has plans for pregnancy during the period of treatment

Patient is part of a vulnerable population (per ISO 14155:2020, individuals who are unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants receive radiation treatment using HyperSight and conventional CBCT imaging technology

6 weeks

Multiple visits for imaging on Day 1, Day 2, and the last day of treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• HyperSight

Trial Overview The study is testing the image quality of HyperSight Imaging technology when used during radiation therapy sessions on a TrueBeam linear accelerator. It's a single-group study focusing on how well this new imaging tech works in practice.

Participant Groups

Group I: HyperSight Imaging arm Experimental Treatment 1 Intervention

Subjects have both HyperSight and conventional CBCT imaging.

HyperSight is already approved in United States for the following indications:

Approved in United States as Varian HyperSight for:

• Radiation therapy for cancer

Who Is Running the Clinical Trial?

Varian, a Siemens Healthineers Company

Lead Sponsor

Trials

35

Recruited

7,200+

Findings from Research

Automated volumetric radiomic analysis of breast cancer vascularization (VAV) significantly improved the prediction of disease-specific survival (DSS) in 314 patients with primary invasive breast cancer, enhancing the standard Nottingham Prognostic Index (NPI) from a predictive accuracy of 75.3% to 81.0%.

The integration of VAV into survival predictions allowed for better identification of patients at higher risk of unfavorable outcomes, with a hazard ratio of 4.5, indicating that VAV can help in selecting patients who may benefit from more aggressive treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated volumetric radiomic analysis of breast cancer vascularization improves survival prediction in primary breast cancer. Dietzel, M., Schulz-Wendtland, R., Ellmann, S., et al.[2021]

Preoperative MRI can detect additional cancers that are not visible through mammography and ultrasound, but its routine use is not recommended due to concerns about increased mastectomy rates and potential overtreatment.

Dynamic contrast-enhanced MRI is the most accurate imaging method for predicting how well patients will respond to neoadjuvant chemotherapy, and ongoing prospective trials are exploring how MRI findings can help reduce the intensity of surgical or radiation treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast Magnetic Resonance Imaging for Patients With Newly Diagnosed Breast Cancer: A Review. Kim, SY., Cho, N.[2023]

Oligometastatic breast cancer (OMBC), characterized by a limited number and sites of metastasis, may achieve definitive remission through personalized treatments like surgery and radiotherapy, suggesting a potential for curative approaches in select cases.

Early detection of metastatic breast cancer using advanced imaging techniques can facilitate timely intervention for OMBC, with specific imaging modalities recommended for different metastatic sites, such as ultrasonography for lymph nodes and CT scans for liver and lung metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnosis of oligometastasis. Terao, M., Niikura, N.[2022]

Routine pre-operative breast MRI is not recommended for women with newly diagnosed early stage breast cancer, as it does not improve clinical outcomes or surgical procedures compared to conventional imaging methods like mammography and ultrasound.

The use of pre-operative breast MRI can lead to potentially harmful changes in clinical management, such as increased rates of mastectomies and delays in definitive surgery, without providing significant benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Counterview: Pre-operative breast MRI (magnetic resonance imaging) is not recommended for all patients with newly diagnosed breast cancer. Solin, LJ.[2017]

Imaging plays a crucial role in improving survival outcomes in cancer care, as evidenced by its effectiveness in various scenarios such as breast cancer screening and staging of non-small cell lung cancer.

Modeling studies suggest that the most significant survival benefits from imaging may be found in mildly symptomatic patients, while even modest improvements in survival can lead to reduced healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can imaging help improve the survival of cancer patients? Miles, K.[2021]

In a study of 12,559 women treated for ductal carcinoma in situ (DCIS), only 52% adhered to annual surveillance imaging guidelines consistently over the first 5 years, indicating a significant gap in guideline adherence.

Racial disparities were evident, with Black and Hispanic women showing lower rates of surveillance imaging compared to White women, and those who underwent imaging had a higher rate of invasive cancer diagnosis, suggesting that surveillance may play a role in early detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surveillance Imaging after Primary Diagnosis of Ductal Carcinoma in Situ. Byng, D., Thomas, SM., Rushing, CN., et al.[2023]

In a study of 3,521 cancer patients, those treated with the immune checkpoint inhibitor ipilimumab (Ipi) and cytokines experienced a significantly higher incidence of acute adverse reactions (ARs) to iodinated contrast media (ICM) during contrast-enhanced computed tomography (CECT) scans, with rates of 12% and 5%, respectively, compared to just 2% in patients receiving standard chemotherapy.

These findings suggest that cancer immunotherapy increases the risk of allergic-like immediate ARs to ICM, highlighting the need for radiologists to closely monitor patients who have undergone immunotherapy to mitigate the risk of severe reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased frequency of acute reactions to iodinated contrast media in cancer patients treated with anti-CTLA-4 immunomodulatory antibodies. Ridolfi, L., De Rosa, F., Petracci, E., et al.[2018]

Immune checkpoint inhibitors (ICIs) have significantly improved outcomes for patients with advanced cancers, leading to more long-term survivors, but these treatments require frequent CT scans that expose patients to considerable radiation.

In a review of 39 clinical trial protocols, it was found that after 10 years of participation, the lifetime cancer risk from radiation exposure due to repeated CT scans could increase to nearly 10% for women and about 6% for men, suggesting a need for adjusted imaging protocols to minimize risks for long-term survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reconsider radiation exposure from imaging during immune checkpoint inhibitor trials to reduce risk of secondary cancers in long-term survivors? Knapen, DG., de Groot, DJA., Kwee, TC., et al.[2020]

In breast cancer clinical trials, the effective imaging radiation dose varies significantly, with adjuvant trials exposing subjects to 0.4-262.2 mSv and metastatic studies to 26-241.3 mSv, indicating a need for careful monitoring of imaging protocols.

The risk of imaging radiation-induced malignancies (IRIMs) is low, with an estimated lifetime attributable risk of 0.0002%-2.41% in adjuvant trials and negligible risk in metastatic trials, suggesting that while some risk exists, it can be minimized by aligning imaging protocols with clinical guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging Radiation Doses and Associated Risks and Benefits in Subjects Participating in Breast Cancer Clinical Trials. Fresco, R., Spera, G., Meyer, C., et al.[2018]

In a study of 37,544 women with a clinical diagnosis of non-high-grade ductal carcinoma in situ (DCIS), 22.2% were found to have invasive carcinoma upon final pathologic examination, highlighting the risk of underestimating invasive cancer in these patients.

Factors such as younger age, negative estrogen receptor status, treatment at academic facilities, and higher income were significantly associated with an upgraded diagnosis of invasive carcinoma, suggesting that these should be considered when deciding on active surveillance for DCIS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Associated With Underestimation of Invasive Cancer in Patients With Ductal Carcinoma In Situ: Precautions for Active Surveillance. Chavez de Paz Villanueva, C., Bonev, V., Senthil, M., et al.[2022]

References

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

Automated volumetric radiomic analysis of breast cancer vascularization improves survival prediction in primary breast cancer. [2021]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Breast Magnetic Resonance Imaging for Patients With Newly Diagnosed Breast Cancer: A Review. [2023]

3. China pubmed.ncbi.nlm.nih.gov

Diagnosis of oligometastasis. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Counterview: Pre-operative breast MRI (magnetic resonance imaging) is not recommended for all patients with newly diagnosed breast cancer. [2017]

5. England pubmed.ncbi.nlm.nih.gov

Can imaging help improve the survival of cancer patients? [2021]

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

Surveillance Imaging after Primary Diagnosis of Ductal Carcinoma in Situ. [2023]

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

Increased frequency of acute reactions to iodinated contrast media in cancer patients treated with anti-CTLA-4 immunomodulatory antibodies. [2018]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Reconsider radiation exposure from imaging during immune checkpoint inhibitor trials to reduce risk of secondary cancers in long-term survivors? [2020]

9. England pubmed.ncbi.nlm.nih.gov

Imaging Radiation Doses and Associated Risks and Benefits in Subjects Participating in Breast Cancer Clinical Trials. [2018]

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

Factors Associated With Underestimation of Invasive Cancer in Patients With Ductal Carcinoma In Situ: Precautions for Active Surveillance. [2022]