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…
ID
Source
Brief title
Condition
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
In patients with colorectal cancer the detection of small nodal metastases with
standard diagnostic imaging (CT and/or MRI) is challenging. This may result in
suboptimal staging and ultimately in suboptimal treatment. Colorectal cancer is
typically associated with a tumour stroma containing large numbers of activated
tumour-associated fibroblasts. Radiolabelled fibroblast activation protein
inhibitor (FAPI) compounds bind selectively to these fibroblasts, and thereby
allow sensitive and specific imaging of tumour stroma with FAPI PET/CT.
Recently published research has indicated that FAPI PET/CT can accurately
detect macroscopic colorectal cancer lesions. We have recently demonstrated
that tumour stroma also develops in lymph node metastases with a tumour
diameter of just a millimetre. Improved detection in the primary tumour area
and in regional lymph nodes provided by FAPI PET/CT may contribute to more
accurate staging with potential impact on patient management e.g., selection
for neoadjuvant treatment. However, until now FAPI PET/CT has mainly been used
to visualise tumour in metastatic patients with various tumour types in the
scope of palliative treatment, and its specific diagnostic value for detection
and locoregional staging of colorectal cancer is currently unknown. We will now
use FAPI PET/CT in a pilot study to explore the potential diagnostic value in
the detection of regional lymph node metastases, and to identify opportunities
for further prospective research in the areas of diagnostics, radiotherapy, and
FAPI-based theragnostic therapy.
Study objective
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.
Study design
Multicentre prospective cross-sectional diagnostic pilot study.
Intervention
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 patients only). In patients with
colon cancer, one FAPI PET/CT scan is added as a diagnostic intervention in the
scope of this study early after standard diagnostic imaging and prior to
planned surgery. In patients with rectal cancer, two FAPI PET/CT scans are
added as diagnostic interventions i.e., for initial staging and restaging (pre
and post neoadjuvant therapy).
Study burden and risks
Participation in this study has no significant risks and will not induce a
delay in diagnosis or treatment because the outcomes of the FAPI PET/CT will
not guide treatment decisions. The FAPI PET/CT scan involves a total procedure
duration of approximately 2 hours and an estimated radiation dose of 6 mSv per
procedure (3 mSv for an administered dose of 200 MBq Fluor-18-FAPI, and 3 mSv
for the associated low dose CT scan). This radiation dose (6 mSv in colon
cancer patients of 18 years and older and 12 mSv in rectal cancer patients of
50 years and older) is well within the range of normal diagnostic procedures
and does not induce a significant risk in the selected population with
colorectal cancer. In addition, the Fluor-18-FAPI radiopharmaceutical is thus
far not associated with side effects after injection.
Plesmanlaan 121
Amsterdam 1066 CX
NL
Plesmanlaan 121
Amsterdam 1066 CX
NL
Listed location countries
Age
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
• 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05209750 |
| CCMO | NL78521.031.21 |