HyperSight Imaging for Cancer

Overseen By Sean Davidson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Varian, a Siemens Healthineers Company

Disqualifiers: Pregnancy, Cardiac devices, Genetic sensitivity, others

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

Compensation: Varies

Number of Visits: Unknown

40 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, which could enhance how doctors plan and deliver radiation therapy for cancer. HyperSight aims to provide clearer images with fewer delays, helping target tumors more accurately while avoiding healthy tissue. Suitable candidates for this trial include those diagnosed with cancer who need radiation treatment for areas like the head, neck, or lungs. The University of Maryland Medical Center conducts the trial. Participants must be able to give consent and will receive radiation therapy as part of their treatment. As an unphased trial, this study offers a unique opportunity to contribute to innovative advancements in cancer treatment.

Do I need to stop my current medications for the HyperSight Imaging 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 use in cancer treatment?

Research has shown that the HyperSight imaging solution provides clearer images than traditional CBCT (cone beam computed tomography) systems. This clarity helps doctors target cancer more accurately during radiation therapy.

Studies have found that HyperSight improves image contrast and reduces blurriness, making it easier to see soft tissues. These improvements can lead to fewer mistakes and more precise treatments. Although these studies focus on image quality, they suggest HyperSight is safe because it enhances visibility without introducing new risks to the imaging process.

Overall, HyperSight appears to be a safe and well-tolerated imaging method, enhancing the accuracy of radiation treatments without compromising patient safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about HyperSight Imaging because it represents a novel approach to cancer detection and monitoring. Unlike traditional imaging methods like MRI and CT scans, HyperSight Imaging uses a cutting-edge CBCT (Cone Beam Computed Tomography) system, which can provide highly detailed 3D images. This technology allows for better visualization of tumors with potentially lower radiation exposure. By offering clearer images and more precise data, HyperSight Imaging could lead to earlier detection and more accurate treatment planning, making it a promising tool in the fight against cancer.

What evidence suggests that HyperSight Imaging is effective for cancer?

Research has shown that HyperSight Imaging, which participants in this trial will receive, greatly improves the quality of cone beam CT (CBCT) scans. Studies indicate that HyperSight reduces image flaws and enhances clarity and detail compared to regular CBCT, resulting in clearer and more accurate images. HyperSight can also capture images in just 6 seconds, helping to prevent blurring from movement. These improvements make HyperSight a promising tool for better targeting in cancer radiation therapy. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals with various cancers (pelvic, head and neck, breast, lung, gastric, gastrointestinal tumors) who require precise radiation therapy. Participants should need image-guided radiation treatment but are not specified by other inclusion or exclusion criteria in the provided information.

Inclusion Criteria

Patient is willing and able to provide written consent.

I have a confirmed cancer diagnosis and need radiation therapy in specific areas.

I am able to get out of my bed or chair and move around.

Exclusion Criteria

I am getting a short course of radiation therapy for symptom relief.

I have a genetic condition that makes me sensitive to radiation.

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"). This includes prisoners.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Evaluation

Subjects are imaged with the new HyperSight CBCT imaging system to evaluate image quality, noise, and artifact levels compared to conventional CT imaging.

1-9 weeks

Multiple imaging sessions

Follow-up

Participants are monitored for safety and effectiveness of the HyperSight imaging system, including patient experience and breath hold tolerance.

1 year

What Are the Treatments Tested in This Trial?

Interventions

• HyperSight Imaging

Trial Overview The study is testing 'HyperSight Imaging,' a new type of imaging technology designed to improve the accuracy of radiation therapy. It aims to overcome limitations like long scan times and poor image quality seen with conventional cone beam computed tomography (CBCT).

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+

Published Research Related to This Trial

In a study of 42 ERCP procedures using cone beam computed tomography (CBCT), it was found that conventional ERCP had a significantly lower median radiation dose compared to CBCT methods, indicating that for simpler procedures, traditional 2-D x-ray techniques are safer in terms of radiation exposure.

However, CBCT can be beneficial for more complex cases, potentially reducing procedural time and the need for additional contrast injections, suggesting that it may improve efficiency in challenging situations despite higher radiation doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation dose in cone beam CT guided ERCP. Waldthaler, A., Reuterwall-Hansson, M., Arnelo, U., et al.[2021]

C-arm Cone Beam CT (CBCT) enhances the safety and accuracy of interventional procedures by providing detailed cross-sectional imaging for preprocedural planning, intraprocedural guidance, and postprocedural assessment.

Despite some technical limitations, such as lower image quality compared to conventional CT and challenges in quantifying radiation doses, CBCT is proving to be a valuable tool in the interventional suite, with the potential for further evolution and integration into clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

C-arm Cone Beam Computed Tomography: A New Tool in the Interventional Suite. Raj, S., Irani, FG., Tay, KH., et al.[2020]

The study demonstrated that the accuracy of Cone Beam Computerized Tomography (CBCT) scans with a 0.2 mm slice thickness remains consistent regardless of the machine warming time, ensuring reliable imaging for clinicians.

When comparing CBCT scans to traditional Computerized Tomography (CT) scans, the differences in accuracy were statistically significant, but not clinically significant, indicating that CBCT can be a viable alternative for head and neck reconstruction imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the accuracy of cone beam computerized tomography (CBCT): medical imaging technology in head and neck reconstruction. Logan, H., Wolfaardt, J., Boulanger, P., et al.[2022]

C-arm cone-beam computed tomography (CBCT) is a cutting-edge imaging technology that enhances interventional oncology by providing detailed cross-sectional images, which can improve treatment planning and navigation.

The integration of CBCT in angiographic systems allows for more precise loco-regional oncological treatments, potentially leading to better patient outcomes in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

C-arm cone-beam computed tomography in interventional oncology: technical aspects and clinical applications. Floridi, C., Radaelli, A., Abi-Jaoudeh, N., et al.[2021]

Cone-beam computed tomography (CBCT) enhances interventional procedures by providing detailed three-dimensional images that improve the localization and targeting of liver tumors compared to standard two-dimensional angiography.

CBCT not only aids in precise microcatheter placement for tumor treatment but also allows for real-time assessment of treatment success, making it a valuable tool in the management of liver cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How I do it: Cone-beam CT during transarterial chemoembolization for liver cancer. Tacher, V., Radaelli, A., Lin, M., et al.[2018]

Three-dimensional cone-beam (CB) imaging provides superior visualization of important anatomical structures compared to digital orthopantomography (OPG) in patients undergoing implant surgery, based on a study of 27 patients.

While CB imaging offers a level of detail comparable to computerized tomography (CT) for high-contrast structures, it is important to consider the higher radiation exposure associated with CB imaging when making clinical decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of cone-beam imaging with orthopantomography and computerized tomography for assessment in presurgical implant dentistry. Dreiseidler, T., Mischkowski, RA., Neugebauer, J., et al.[2022]

The average effective dose (ED) of radiation from abdominal C-arm cone beam computed tomography (CBCT) was found to be 4.3 mSv, which is significantly higher in the upper abdomen compared to the lower abdomen and increases with patient weight.

The radiation exposure from CBCT is comparable to approximately 7.2 minutes of fluoroscopy, and the lifetime risk of cancer death from this exposure is estimated to be 0.033% or less, indicating a relatively low risk associated with this imaging technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation exposure of abdominal cone beam computed tomography. Sailer, AM., Schurink, GW., Wildberger, JE., et al.[2015]

The study found that a single megavoltage (MV) cone beam computed tomography (CBCT) scan increases the skin dose in the treatment area, with doses ranging from 0.5 to 1.4 Gy on the treated breast, which could raise concerns about potential toxicity and secondary cancer risks.

The additional skin dose from the MV CBCT was relatively low (0.02 to 0.05 Gy), but it still increased the overall out-of-field skin dose by about 20%, highlighting the need for careful consideration of imaging doses in clinical protocols for breast radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Megavoltage cone beam CT near surface dose measurements: potential implications for breast radiotherapy. Quinn, A., Holloway, L., Cutajar, D., et al.[2017]

The HyperSight cone beam computed tomography (CBCT) system significantly reduces image artifacts compared to the standard TrueBeam system, providing image quality comparable to fan beam CT (CTsim) in just 6 seconds of acquisition time.

HyperSight breath hold imaging (HSBH) offers improved image uniformity and a contrast-to-noise ratio over free breathing imaging, making it a valuable tool for accurate dose calculations in adaptive radiation therapy workflows.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Technology Allowing Cone Beam Computed Tomography in 6 Seconds: A Patient Study of Comparative Image Quality. Robar, JL., Cherpak, A., MacDonald, RL., et al.[2023]

The multi-turn reverse helical scan significantly increased the longitudinal field of view in intraoperative CBCT imaging from 17 cm to 80 cm, enhancing the visualization of long anatomical sites during procedures.

This new imaging technique demonstrated high geometric accuracy (0.2 mm and 0.2 degrees) and excellent observer reliability (intraclass correlation coefficient above 0.900), making it a promising tool for assessing surgical interventions like pedicle screw placements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended Intraoperative Longitudinal 3-Dimensional Cone Beam Computed Tomography Imaging With a Continuous Multi-Turn Reverse Helical Scan. Reynolds, T., Ma, YQ., Kanawati, AJ., et al.[2023]

Cone-beam computed tomography (CBCT) is a reliable diagnostic tool for assessing conditions like impacted canines and root fractures in children, providing better evaluation of condylar shape and volume compared to conventional imaging.

CBCT is particularly advantageous for pre-surgical diagnostics in cases like cleft lip and palate due to its lower radiation exposure, shorter investigation time, and cost-effectiveness, but it should only be used when traditional radiography fails to provide a clear diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CBCT in orthodontics: a systematic review on justification of CBCT in a paediatric population prior to orthodontic treatment. De Grauwe, A., Ayaz, I., Shujaat, S., et al.[2020]

A survey of 320 dental students revealed that 96.9% were aware of cone-beam computed tomography (CBCT) and recognized its lower radiation dose as a key advantage over traditional medical CT, indicating a strong foundational knowledge of this imaging technology.

The majority of students expressed a desire for more education on CBCT during their clinical training and anticipated its increased use in their future dental practices, highlighting the need for enhanced practical training in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dental students' knowledge and attitude towards cone-beam computed tomography: An Indian scenario. Shah, PH., Venkatesh, R.[2018]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1879850023002953

Novel Technology Allowing Cone Beam Computed ... The HyperSight system provides 6-second CBCT acquisition with image artifacts that are significantly reduced compared with TrueBeam and comparable to those in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10475190/

Review of cone beam computed tomography based online ... PD-0662 Evaluation of Ethos HyperSight imaging performance compared to standard CBCT and FBCT. In: European Society of Radiotherapy and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06681233

Feasibility Study of CBCT for IGRT in Cancer Patients This study is being done to evaluate the image quality of HyperSight CBCT compared to conventional CBCT images, and to determine whether HyperSight CBCT can ...

4. advancesradonc.org advancesradonc.org/article/S2452-1094(24)00244-6/fulltext

Comprehensive Image Quality Evaluation and Motion ... Significant improvement of image contrast, HU constancy, and noise level on HyperSight CBCT was observed compared with TrueBeam CBCT. Significant image quality ...

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

Feasibility of HyperSight CBCT for adaptive radiation therapy End‐to‐end results using the RANDO anthropomorphic phantom indicate that HyperSight CBCT images are suitable for radiation treatment planning.

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. clinicaltrials.gov clinicaltrials.gov/study/NCT06681233

Feasibility Study of CBCT for IGRT in Cancer Patients The difference in image uniformity will be evaluated between a standard CBCT image, a CBCT image acquired using HyperSight technology, and a standard fan-beam ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39717196/

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 ...

9. phiro.science phiro.science/article/S2405-6316(24)00157-X/fulltext

Evaluation of artificial intelligence-based autosegmentation ... This study evaluates the impact of this high-performance CBCT on autosegmentation performance, inter-observer variability, contour correction times and ...

10. 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.