High-resolution imaging to check if tumors are completely removed during surgery
High-resolution PET-CT Specimen Imaging for the Perioperative Visualization of Resection Margins: an Exploratory Pilot Study
This study is testing if high-resolution imaging during surgery can help make sure all tumors are removed in patients with different types of cancer, like breast, prostate, and thyroid, to improve their treatment outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Algemeen Ziekenhuis Maria Middelares Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Ghent, Oost Vlaanderen) |
| Trial ID | NCT06835426 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of high-resolution PET-CT imaging during surgery to ensure complete removal of tumors in patients with various cancers, including breast, prostate, and thyroid cancers. By using a radiotracer and imaging the excised tissue, the study aims to provide immediate feedback on whether additional tissue needs to be removed, potentially reducing the need for further treatments. The study will also compare the imaging results with traditional microscopic analysis to assess accuracy and safety. The goal is to improve surgical outcomes and reduce patient stress and costs associated with delayed results.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with breast, prostate, thyroid, or skin cancers who are scheduled for resective surgery.
Not a fit: Patients with tumors that do not require surgical intervention or those who are not candidates for resective surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective surgeries with fewer follow-up treatments for patients.
How similar studies have performed: While the use of imaging techniques in surgery is established, the specific application of high-resolution PET-CT for real-time margin assessment is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
A. Inclusion Criteria: * able to understand treatment protocol and informed consent form * estimated by the investigator to be compliant for study participation 1\. Fulfilling all group-specific inclusion criteria: * confirmed breast cancer with an indication to undergo breast conserving surgery * confirmed prostate cancer with an indication to undergo resective surgeryprostatectomy; * confirmed thyroid lesion with an indication to undergo resective surgery; * confirmed parathyroid adenoma with an indication to undergo resective surgery; * suspected basal cell carcinoma, squamous cell carcinoma or melanoma with an indication to undergo resective surgery; * suspected lesion in genitourinary sites (including bladder cancer, renal pelvis and ureter carcinoma, adrenal cortical carcinoma and renal cell carcinoma) with an indication to undergo resective surgery; * suspected lesion in the head \& neck region with an indication to undergo resective surgery; * confirmed primary or secondary hepatobiliary cancer with an indication to undergo resective surgery; * patients undergoing biopsy after metabolic active lesions were detected on a PET scan. * suspected neuro-endocrine malignancies with an indication to undergo resective surgery. * suspected brain tumor with an indication to undergo resective surgery. * Suspected malignant and benign gastrointestinal lesions with an indication to undergo resective surgery. * suspected malignant thoracovascular lesions with an indication to undergo resective surgery B. Exclusion Criteria: * general or local contra-indications for resective surgery; * in case of FDG-based PET tracers: a blood glucose level over 200 mg/dL on the day of surgery; * pregnancy or lactation; * participation in other clinical studies with a radiation exposure of more than 1 mSv in the past year.
Where this trial is running
Ghent, Oost Vlaanderen
- AZ Maria Middelares — Ghent, Oost Vlaanderen, Belgium (Recruiting)
Study contacts
- Study coordinator: Tessa Van Oostveldt
- Email: klinische.studies@mijnziekenhuis.be
- Phone: +3292468000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.