Imaging tumor angiogenesis using 18F-Fluciclatide PET/CT in patients with colorectal and pancreatic cancer.

Phase 2

Recruiting

• Conditions: 10017990; 10017991; bowel cancer; pancreatic cancer.

• Registration Number: NL-OMON54757
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Biopsy proven primary colorectal adenocarcinoma or suspected pancreatic ductal
adenocarcinoma, as agreed on by multidisciplinary team;
No prior chemo(radio)therapy in rectal cancer patients.
Patients treated in the LUMC.
Before patient registration, written informed consent must be given according
to ICH/GCP, and national/local regulations.

Exclusion Criteria

Contraindication for PET (pregnancy, breast-feeding and severe claustrophobia);
Impaired renal function (creatinine clearance < 60 mL/min according to the
Cockcroft-Gault equation or ureum < 2x ULN (Upper limit of normal);
Impaired liver function (ALAT, ASAT > 3 ULN or total bilirubin >2x ULN);
Known allergy to pABA (p-aminobenzoate sodium salt);
Presence of any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up
schedule;
Inability to tolerate lying supine for the duration of a PET/CT examination
(~30min).

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Sensitivity/specificity of 18F-Fluciclatide. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Optimal imaging window of this tracer<br /><br>Feasibility of responsemonitoring with this tracer</p><br>