HyperSight Imaging for Pelvic Cancer

Overseen By Sean Davidson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Varian, a Siemens Healthineers Company

Disqualifiers: Vulnerable populations, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging system called HyperSight to enhance image quality during radiation therapy for pelvic cancer. The researchers aim to determine if HyperSight images surpass standard ones in planning and delivering radiation treatment accurately. Participants will not experience any changes to their treatment by joining the study. It suits individuals receiving radiation therapy to areas such as the head, neck, chest, abdomen, or pelvis. As an unphased trial, it provides a unique opportunity to contribute to advancements in imaging technology without altering the current treatment plan.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems the study focuses on imaging and does not directly affect your treatment, so you may not need to change your medications, but it's best to confirm with the study team.

What prior data suggests that the HyperSight imaging system is safe for use in pelvic cancer patients?

Research shows that HyperSight imaging is still under study, and specific safety data is not yet available. However, this imaging system does not alter the delivery of radiation treatment; it simply enhances visual clarity for doctors.

In studies, HyperSight has improved image quality during radiation therapy, aiding doctors in planning and delivering treatment more accurately. The focus has been on image quality rather than direct patient effects.

Since HyperSight integrates with existing, approved systems, it is considered safe to try. Various studies have tested it on people, supporting its safety. However, due to the lack of direct safety data, anyone considering participation in a study should consult their doctor to understand all potential risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about HyperSight imaging for pelvic cancer because it offers a new way to visualize tumors using a cutting-edge Cone Beam Computed Tomography (CBCT) system. Unlike traditional imaging techniques, such as MRI or standard CT scans, HyperSight provides enhanced 3D images with potentially higher resolution and better accuracy in identifying cancerous tissues. This could lead to more precise treatment planning and improved outcomes for patients, making it a promising tool in the fight against pelvic cancer.

What evidence suggests that the HyperSight imaging system is effective for pelvic cancer?

Research has shown that HyperSight imaging, which participants in this trial will receive, significantly enhances the quality of CBCT (cone beam computed tomography) images. Studies have found that HyperSight achieves dose calculation accuracy within 1% of standard CT (computed tomography) images when used for treating pelvic cancer. This results in clearer and more precise images, aiding doctors in planning radiation treatments more effectively. Additionally, HyperSight images exhibit higher gamma passing rates, indicating greater reliability for verifying radiation doses. Overall, these findings suggest that HyperSight imaging could greatly improve the evaluation and planning of treatments for pelvic cancer. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults who are set to receive radiation therapy for cancers in the head, neck, thorax, abdomen, or pelvis. They must have good kidney function if receiving IV contrast and women of childbearing age need a negative pregnancy test. It's not open to those unable to consent or considered vulnerable.

Inclusion Criteria

My kidneys work well enough for IV contrast, with an eGFR over 30.

I can join the study without a kidney test if I'm not getting IV contrast.

I am scheduled for radiation therapy on my head, neck, chest, abdomen, or pelvis.

Exclusion Criteria

Patient is unwilling or unable to sign an IRB-approved written informed consent document

I am not in a position to fully understand or decide about participating in this study without influence.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging

Participants are imaged with the new HyperSight CBCT imaging system to evaluate integration with the TrueBeam radiotherapy system

1-9 weeks

Multiple imaging sessions

Follow-up

Participants are monitored for image quality and utility in radiotherapy workflow

1-9 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HyperSight imaging

Trial Overview The study tests HyperSight imaging integrated with the TrueBeam radiotherapy system by Varian Medical Systems. The goal is to see if this new CBCT imaging can provide clearer images than conventional methods without affecting patients' ongoing radiation treatments.

How Is the Trial Designed?

Group I: HyperSight Imaging arm Experimental Treatment 1 Intervention

Subjects are imaged with the new HyperSight CBCT imaging system.

Who Is Running the Clinical Trial?

Varian, a Siemens Healthineers Company

Lead Sponsor

Trials

35

Recruited

7,200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12059299/

Assessing HyperSight iterative CBCT for dose calculation ... Here we present a comprehensive evaluation of the dosimetric performance of direct HS‐iCBCT dose calculation in pelvis and breast oART patient treatments, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05975619

A Prospective Imaging Study of the Integrated TrueBeam- ... The purpose of this study is to evaluate the integration of the HyperSight imaging system with Varian's TrueBeam radiotherapy system.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1120179725002017

Evaluation of the dosimetric accuracy of HyperSight CBCT ... Dose recalculations on Acuros images resulted in higher gamma passing rates, particularly in pelvic cases (97.8 % vs 96.6 % with FDK, p < 0.05). HU stability ...

4. ro-journal.biomedcentral.com ro-journal.biomedcentral.com/articles/10.1186/s13014-025-02730-8

Advanced HyperSight™ imaging for patients with adaptive ... This study evaluated the longitudinal image quality of the novel HyperSightTM-CBCT (hCBCT) compared to planning CT (pCT), using phantoms and ...

5. aapm.onlinelibrary.wiley.com aapm.onlinelibrary.wiley.com/doi/10.1002/acm2.70245

Feasibility of HyperSight CBCT for adaptive radiation therapy ... In this study, the accuracy of dose calculations performed on HyperSight CBCT was found to be within 1% of CTsim calculations for pelvic and ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/K232113.pdf

Varian Medical Systems Inc. November 3, 2023 Lynn Allman ... A data set consisting of 26 human subject cases was obtained from three institutions in. US and Europe utilizing HyperSight imaging in ...

7. varian.com varian.com/products/radiotherapy/treatment-delivery/hypersight

HyperSight The image reconstruction algorithms and the increased FOV delivers improved visualization of the patient volume and surrounding organs at risk (OARs)—enabling ...

8. withpower.com withpower.com/trial/phase-thoracic-cancers-7-2024-32b6c

HyperSight Imaging for Cancer Is HyperSight Imaging generally safe for humans? The research articles provided do not contain specific safety data for HyperSight Imaging or its related names.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12529831/

Advanced HyperSight™ imaging for patients with adaptive ... This study evaluated the longitudinal image quality of the novel HyperSightTM-CBCT (hCBCT) compared to planning CT (pCT), using phantoms and ...