NCT05209750

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
Completed

Started Jul 2022

Typical duration for not_applicable colorectal-cancer

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

July 13, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

2.6 years

First QC Date

January 13, 2022

Last Update Submit

September 20, 2023

Conditions

Colorectal Cancer

Keywords

Lymph nodeStagingFAPIPET/CTRectal cancerColon cancer

Outcome Measures

Primary Outcomes (3)

  • Presence of lymph node metastases on FAPI PET/CT

    Comparison: diagnostic contrast enhanced CT abdomen for colon cancer patients and diagnostic MRI for rectal cancer patients. Reference test: histopathology after surgery.

    <4 weeks from diagnosis for colon cancer and 10-17 weeks from diagnosis for rectal cancer

  • Number of positive regional lymph nodes (count)

    Comparison: diagnostic contrast enhanced CT abdomen for colon cancer patients and diagnostic MRI for rectal cancer patients. Reference test: histopathology after surgery.

    <4 weeks from diagnosis for colon cancer and 10-17 weeks from diagnosis for rectal cancer

  • True malignant node (yes/no)

    Comparison: diagnostic contrast enhanced CT abdomen for colon cancer patients and diagnostic MRI for rectal cancer patients Comparison: diagnostic contrast enhanced CT abdomen for colon cancer patients and MRI after neoadjuvant treatment for rectal cancer patients

    <4 weeks from diagnosis for colon cancer and 10-17 weeks from diagnosis for rectal cancer

Secondary Outcomes (3)

  • To describe additional findings on FAPI PET/CT i.e., structures with tracer uptake not including the primary tumour and/or regional lymph nodes.

    <4 weeks from diagnosis

  • To describe the correlation between tumour stroma in resected lymph node metastases and tracer uptake of lymph nodes on FAPI PET/CT.

    <4 weeks from diagnosis for colon cancer and 10-17 weeks from diagnosis for rectal cancer

  • To describe the value of FAPI PET/CT on tumour response evaluation following neoadjuvant treatment.

    10-17 weeks from diagnosis for rectal cancer

Study Arms (1)

FAPI PET/CT

EXPERIMENTAL

Colon cancer patients: one FAPI PET/CT scan early after standard diagnostic imaging and prior to planned surgery. Rectal cancer patients: two FAPI PET/CT scans, one for initial staging (pre neoadjuvant therapy) and one for restaging (post neoadjuvant therapy).

Diagnostic Test: FAPI PET/CT

Interventions

FAPI PET/CTDIAGNOSTIC_TEST

This study applies the radiopharmaceutical 18Fluor-FAPI-74 (shortly called FAPI) for molecular imaging of FAP expression in vivo with FAPI PET/CT, to assess the presence and distribution of activated tumour-associated fibroblasts as a marker of tumour stroma and indirectly as a marker of CRC.

Also known as: Fluor-18-FAPI-74
FAPI PET/CT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Biopsy proven newly detected adenocarcinoma of the colon or rectum
  • 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)
  • 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
  • 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 \* Related to the allowed radiation dose per age category for diagnostic imaging and in accordance with the guideline of the Dutch Commission for Radiation Dosimetry (NCS).

You may not qualify if:

  • Inability to provide informed consent
  • Histopathology of mucinous adenocarcinoma
  • WHO \> 2
  • 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 colorectal cancer diagnosis
  • 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
  • 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:
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Noordwest ziekenhuisgroep

Alkmaar, North Holland, 1815JD, Netherlands

NOT YET RECRUITING

Netherlands Cancer Institute

Amsterdam, North Holland, 1066CX, Netherlands

RECRUITING

MeSH Terms

Conditions

Colorectal NeoplasmsRectal NeoplasmsColonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Wouter V Vogel, MD, PhD

CONTACT

+31(0)205129111w.vogel@nki.nl

Alice M Couwenberg, MD, PhD

CONTACT

+31(0)205129111a.couwenberg@nki.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Interventional study without concurrent controls
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2022

First Posted

January 27, 2022

Study Start

July 13, 2022

Primary Completion

March 1, 2025

Study Completion

September 1, 2025

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

NL(2)