TheranosticTrials.org

Clinical Trial · NCT05209750

FAPI PET/CT for Lymph Node Staging in Colorectal Carcinoma

Overview

To describe the accuracy of FAPI PET/CT in the detection of regional lymph node metastases in patients with colorectal cancer in comparison with standard diagnostic imaging and (in operated patients) histopathology, aiming to provide early evidence of the diagnostic value of FAPI PET/CT.

Sponsor

The Netherlands Cancer Institute

Phase

N/A

Contacts

Wouter V Vogel, MD, PhD (CONTACT)

w.vogel@nki.nl

+31(0)205129111

Alice M Couwenberg, MD, PhD (CONTACT)

a.couwenberg@nki.nl

+31(0)205129111

ClinicalTrials.gov

NCT05209750

Drug / Compound

FAPI-74

Isotope(s):
Target(s):
  • FAP
Ligand Class: Small Molecules
Chelator: NOTA

Eligibility

Inclusion

  • Indication for curative local treatment of the primary colon/rectal tumour
  • Indication for surgery including resection of the colon tumour and the corresponding mesentery
  • Surgery can be planned within 5 weeks after diagnostic imaging
  • Planned for response assessment after (chemo)radiotherapy with pelvic MRI
  • cTany N1-2 Many 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)
  • Surgery takes place in one of the participating centres of this studyFor rectal cancer patients:
  • Indication for neoadjuvant (chemo)radiotherapy of the rectal tumour
  • Biopsy proven newly detected adenocarcinoma of the colon or rectum

Exclusion

  • Absence of response assessment after (chemo)radiotherapy
  • Suspicion of peritoneal metastases based on contrast-enhanced CT and/or MRI
  • Refusal of surgery by the patient
  • Indication for neoadjuvant treatment
  • WHO \> 2
  • Indication for emergency surgeryFor rectal cancer patients:
  • Treatment setting without local treatment of the primary colorectal tumourFor colon cancer patients:
  • Absence of diagnostic contrast enhanced-CT thorax-abdomen
  • Histopathology of mucinous adenocarcinoma
  • Refusal of neoadjuvant treatment by the patient
  • Absence of diagnostic pelvic MRI and/or contrast enhanced-CT thorax-abdomen
  • Lactation, unable to substitute for 24 hours after FAPI PET/CT