Ultrasound and Photoacoustic Imaging for Enhanced Differential Diagnosis of Rectal Cancer
Diagnosis and Risk Assessment of Locally Advanced Rectal Cancer Using Co-registered Ultrasound and Photoacoustic Imaging
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 19 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Ultrasound, MRI scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "The purpose of this study is to demonstrate the functionality of a novel endorectal photoacoustic ultrasound imaging modality in humans with rectal cancer."
- "Investigators hypothesize that a co-registered photoacoustic ultrasound endorectal device can significantly reduce unnecessary surgeries in rectal cancer patients with complete clinical response while maintaining high sensitivity in identifying those with residual cancer."
- "The investigators hypothesize that a co-registered photoacoustic ultrasound endorectal device can significantly reduce unnecessary surgeries in rectal cancer patients with complete clinical response while maintaining high sensitivity in identifying those with residual cancer."
- "Eligible patients will include those with rectal cancer who received neoadjuvant therapy and were deemed to either have incomplete or indeterminant or clinical response based on standard endoscopy and axial imaging with magnetic resonance."
- "After initial training using group #1 data, the study surgeon will grade the tumor bed based on MRI and other clinical information as non-cCR or cCR at the time of SOC imaging after treatment completion."
- "The radiologist reader will also independently grade each case based on MRI."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests a device placed inside the rectum that uses light and sound waves to make images. It is for adults with rectal cancer who are having surgery. Researchers want to see if it can find cancer left after treatment before surgery and help avoid surgery when no cancer is found.
The purpose of this study is to demonstrate the functionality of a novel endorectal photoacoustic ultrasound imaging modality in humans with rectal cancer. The study involves testing a previously developed endorectal device to determine its ability to accurately assess rectal tumor response to preoperative treatment. Investigators hypothesize that a co-registered photoacoustic ultrasound endorectal device can significantly reduce unnecessary surgeries in rectal cancer patients with complete clinical response while maintaining high sensitivity in identifying those with residual cancer.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have rectal cancer at any stage and be having surgery to remove it.
- Be older than 18.
- Be able to understand the study and agree to take part.
- For imaging inside the body, the tumor must be within 15 centimeters of the opening of the anus.
- For image reviewers: Be a colon and rectal surgeon or an imaging doctor who regularly treats people with rectal cancer or reads their scans.
Who can't join
- Cannot understand the study and agree to take part.
- Have a tissue sample collected during surgery for a frozen section test, a quick test of frozen tissue.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria Patients: * Patients with any stage of rectal cancer undergoing surgical resection. * Age \>18 years * Able to provide informed consent Additional Inclusion Criterion for in vivo imaging (patients): * Lesion located within 15cm of the anal verge Exclusion Criteria Patients: * Inability to provide consent * Collection of intraoperative specimen for frozen section analysis will disqualify patients from participation Eligibility Criteria Readers: * Colorectal surgeons or radiologists who treat or interpret imaging regularly for patients with rectal cancer.
Study sites (1)
MO
- Washington University School of Medicine · St Louis, MO 63110William Chapman, Jr., M.D. · Study contact · 314-454-7177 · chapmanjr@wustl.eduWilliam Chapman, Jr., M.D. · Principal investigatorQuing Zhu, Ph.D. · Sub-investigatorAdam Booth, M.D. · Sub-investigatorMore trials in St Louis