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

Trial Summary

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 data supports the effectiveness of the treatment HyperSight Imaging for cancer?

The research shows that HyperSight Imaging, a type of cone beam computed tomography (CBCT), provides high-quality images quickly, which can be useful in guiding cancer treatments. This technology is also being used in other medical procedures due to its ability to offer detailed images, suggesting it could be effective in cancer treatment as well. ^{1 2 3 4 5}

Is HyperSight Imaging generally safe for humans?

Research on similar imaging technology, cone beam computed tomography (CBCT), shows that while it is useful, there are concerns about radiation exposure. Studies highlight the importance of understanding and managing radiation doses to ensure patient safety. ^{6 7 8 9 10}

How is the HyperSight Imaging treatment different from other cancer treatments?

HyperSight Imaging uses a novel cone beam computed tomography (CBCT) platform that provides rapid and high-quality imaging, which can enhance the precision of cancer treatments by allowing better visualization and targeting of tumors compared to traditional imaging methods. ^{1 2 3 11 12}

What is the purpose of this trial?

The primary objective of radiation therapy is to deliver a therapeutic dose of radiation precisely to the target while minimizing exposure to healthy surrounding tissues. Image-guided radiation therapy (IGRT) involves acquiring cone beam computed tomography (CBCT) scans just before or during treatment sessions. By comparing the CBCT images with the reference images from the treatment planning process, clinicians can make necessary adjustments to ensure precise targeting and account for any changes that may have occurred since the initial planning. Conventional CBCT technology is, however, limited by several factors including long acquisition times that result in motion artifacts in the image, smaller fields of view that limit the volume of anatomy that can be imaged, poor image quality that limits soft tissue visibility, and artifacts created by dense metal implants. This study will evaluate a novel CBCT imaging solution ("HyperSight") that has the potential to address the challenges of conventional CBCT.

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

References

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

Novel Technology Allowing Cone Beam Computed Tomography in 6 Seconds: A Patient Study of Comparative Image Quality. [2023]

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

Extended Intraoperative Longitudinal 3-Dimensional Cone Beam Computed Tomography Imaging With a Continuous Multi-Turn Reverse Helical Scan. [2023]

3. Singapore pubmed.ncbi.nlm.nih.gov

C-arm Cone Beam Computed Tomography: A New Tool in the Interventional Suite. [2020]

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

Comparison of cone-beam imaging with orthopantomography and computerized tomography for assessment in presurgical implant dentistry. [2022]

5. India pubmed.ncbi.nlm.nih.gov

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

6. Ireland pubmed.ncbi.nlm.nih.gov

Radiation dose in cone beam CT guided ERCP. [2021]

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

Radiation exposure of abdominal cone beam computed tomography. [2015]

8. England pubmed.ncbi.nlm.nih.gov

Evaluation of the accuracy of cone beam computerized tomography (CBCT): medical imaging technology in head and neck reconstruction. [2022]

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

CBCT in orthodontics: a systematic review on justification of CBCT in a paediatric population prior to orthodontic treatment. [2020]

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

Megavoltage cone beam CT near surface dose measurements: potential implications for breast radiotherapy. [2017]

11. Italy pubmed.ncbi.nlm.nih.gov

C-arm cone-beam computed tomography in interventional oncology: technical aspects and clinical applications. [2021]

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

How I do it: Cone-beam CT during transarterial chemoembolization for liver cancer. [2018]