Bowel cancer colorectal cancer
Conditions
Interventions
Participants receive standard diagnostic imaging with contrast enhanced CT
thorax-abdomen (all patients) and pelvic MRI for initial staging and restaging
after neoadjuvant treatment (rectal cancer p
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Biopsy proven newly detected adenocarcinoma of the colon or rectum • cT(any) N1-2 M(any) using TNM 8th edition and based on standard diagnostic imaging including contrast enhanced-CT thorax-abdomen (for colon and rectum) and pelvic MRI (for rectum) • Indication for curative local treatment of the primary colon/rectal tumour • Signed written informed consent prior to any study specific procedure For colon cancer patients: • Age 18 years and older • Indication for surgery including resection of the colon tumour and the corresponding mesentery • Surgery can be planned within 5 weeks after diagnostic imaging • Surgery takes place in one of the participating centres of this study For rectal cancer patients: • Age 50 years and older • Indication for neoadjuvant (chemo)radiotherapy of the rectal tumour • Planned for response assessment after (chemo)radiotherapy with pelvic MRI • Planned for surgery or an organ preservation approach in one of the participating centres of this study
Exclusion criteria
Exclusion criteria: • WHO 0-2 • Histopathology of mucinous adenocarcinoma • Inability to provide informed consent • Pregnancy • Lactation, unable to substitute for 24 hours after FAPI PET/CT • Known second malignant disease that may complicate image interpretation including a second primary at time of diagnosis CRC • Inability to cooperate with the scan process: inability to lie relatively still and in supine for 30-60 minutes or patient body habitus above scanner dimensions • Suspicion of peritoneal metastases based on contrast-enhanced CT and/or MRI abdomen • Treatment setting without local treatment of the primary colorectal tumour For colon cancer patients: • Absence of diagnostic contrast enhanced-CT thorax-abdomen • Refusal of surgery by the patient • Indication for neoadjuvant treatment • Indication for emergency surgery For rectal cancer patients: • Contra-indication for MRI • Absence of diagnostic pelvic MRI and/or contrast enhanced-CT thorax-abdomen • Refusal of neoadjuvant treatment by the patient • Absence of response assessment after (chemo)radiotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main objective is to describe the diagnostic accuracy of FAPI PET/CT in detecting regional lymph node metastases relative to standard of care diagnostic imaging. FAPI PET/CT will be visually correlated with contrast-enhanced CT in colon cancer patients, and pelvic MRI pre- and post-neoadjuvant treatment in rectal cancer patients. Histopathology of the resected specimen will serve as reference test for operated patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include description of additional findings on FAPI PET/CT. Also, the correlation between tumour stroma in resected lymph node metastases and tracer uptake of regional lymph nodes on FAPI PET/CT including analyses of de FAP protein in the tumor stroma. Also, evaluation of response to neoadjuvant treatment on FAPI PET/CT in rectal cancer. All outcomes are descriptive and serve as pilot for a potential subsequent larger prospective diagnostic study. | — |
Countries
Netherlands
Outcome results
None listed