HyperSight Imaging for Cancer

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Varian, a Siemens Healthineers Company

Disqualifiers: Pregnancy, Vulnerable populations

No Placebo Group

Approved in 1 Jurisdiction

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}

Research Team

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

I am 18 years old or older.

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.

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)

Trial 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 (Imaging Device)

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.

Who Is Running the Clinical Trial?

Varian, a Siemens Healthineers Company

Lead Sponsor

Trials

35

Recruited

7,200+

Findings from Research

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]

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]

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]