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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging technology called HyperSight (also known as Varian HyperSight) to determine if it can improve image quality for cancer patients undergoing radiation treatment. The researchers aim to compare this new imaging with the usual method to identify which provides better pictures during treatment. Cancer patients, such as those with tumors in the head, neck, or other specified areas, who are already scheduled for radiation therapy, might be suitable for this study. Participants will undergo both the new and standard imaging to evaluate the differences. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance imaging techniques for future cancer treatments.

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 prior data suggests that HyperSight imaging is safe for cancer patients?

Research shows that HyperSight imaging is being tested for safety and effectiveness in cancer treatment. Although specific safety data remains limited, this technology aims to clarify images used during radiation therapy, potentially improving treatment outcomes without introducing new risks.

No direct evidence of safety issues has emerged in existing studies. Additionally, HyperSight is not new to medicine; it has been used in other areas and received positive feedback. The lack of reports on negative effects suggests it might be safe.

Overall, while more information would be beneficial, current research suggests that HyperSight is unlikely to pose major safety risks for patients undergoing imaging during cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about HyperSight Imaging for cancer because it offers a new way to visualize tumors more accurately. Unlike traditional Cone Beam CT (CBCT) imaging, HyperSight provides enhanced imaging clarity, potentially allowing doctors to detect cancerous tissues earlier and with more precision. This could lead to better treatment planning and improved outcomes for patients, making HyperSight a promising advancement in cancer diagnostics.

What evidence suggests that HyperSight imaging is effective for cancer?

Research has shown that HyperSight imaging, which participants in this trial will receive, is highly effective for cancer patients undergoing radiation treatment. One study found that dose calculations with HyperSight CBCT matched the accuracy of traditional CT scans, particularly in the pelvic area, with only a 1% difference. Another study demonstrated that HyperSight offers clearer images than regular CBCT, with improved contrast and reduced noise. This clarity allows doctors to obtain images more quickly, aiding in more precise treatment decisions. Overall, HyperSight reduces image distortions, resulting in more reliable outcomes during cancer treatment. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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 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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12419991/

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 ...

2.

varian.com

varian.com/resources-support/blogs/hypersight-imaging-solution-revolution-resolution-single

The HyperSight Imaging Solution: A Revolution in ...

HyperSight brings fast, highly accurate imaging into the treatment room. It enables the acquisition of cone-beam CT (CBCT) images in as little as six seconds.

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S2452109424002446

Comprehensive Image Quality Evaluation and Motion ...

This evaluation shows significant image improvement of HyperSight CBCT over conventional CBCT on image contrast, HU constancy, and noise level.

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.

withpower.com

withpower.com/trial/phase-pelvic-cancer-1-2024-54b7f

HyperSight Imaging for Cancer

The HyperSight cone beam computed tomography (CBCT) system significantly reduces image artifacts compared to the standard TrueBeam system, providing image ...

6.

varian.com

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

HyperSight

"The new HyperSight imaging solution on Halcyon offers improved image quality with CT number accuracy comparable to planning CT, which may lead to improved dose ...

7.

pmc.ncbi.nlm.nih.gov

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

Advanced HyperSight™ imaging for patients with adaptive ...

Inter-observer agreement was moderate, with lower rating score for resident compared to the experienced radiation oncologist (p < 0.001).

8.

nature.com

nature.com/articles/s41598-025-99920-x

CBCT based radiomic features in patients with CT guided ...

This study comprehensively evaluates the stability of radiomic features, as potential imaging biomarkers, in pelvic structures of prostate cancer patients.

9.

sciencedirect.com

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

Evaluation of the dosimetric accuracy of HyperSight CBCT ...

This study provides the first comprehensive, multi-site and longitudinal clinical validation of HyperSight CBCT with Acuros reconstruction for ART workflows.