18F-PSMA PET-CT as a potential novel imaging modality for pancreatic cancer: A pilot study

Phase 1

• Conditions: Patients with clinically suspected (borderline) resectable pancreatic ductal adenocarcinoma with an indication for standard surgical treatment with adjuvant chemotherapy will be included; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-002185-14-NL
• Lead Sponsor: Amsterdam University Medical Center - location VUmc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-26
• Last Update Posted: 26 October 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

-Patients aged 18 years or older
-Diagnosis of suspected pancreatic ductal adenocarcinoma and eligible for surgery
-Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

-Patients with metastatic PDAC on conventional imaging will be excluded, as current guidelines exclude them from surgery because of no survival benefit.
-Women who are pregnant and/or or lactating.
-Medical or psychiatric conditions that compromise the patient’s ability to give informed consent. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
-Prior radiotherapy to the abdomen and/or thorax.
-Known hypersensitivity to drugs comparative to 18F-PSMA, or any of their excipients or to any component of 18F-PSMA.
-Inability to undergo PET-CT scanning (e .g. claustrophobia, weight limits or inability to tolerate lying for the duration of a PET-CT scan (~30 min).
-Inability to undergo routine MRI or CT scans as part of the diagnostic work up.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary objective: To determine if PDAC can be detected by 18F-PSMA PET-CT imaging. <br>;Secondary Objective: Secondary objectives:<br>-To assess the agreement between the 18F-PSMA PET-CT imaging signal in PDAC and histopathologic evidence of cancer and PSMA expression on the resection specimen.<br>-To assess the lower limit of PSMA expression on tissue samples still resulting in detectable trace uptake (18F-PSMA positivity”) on the PET scan (quantitative” evaluation). This in order to select eligible patients for PSMA-based therapy in the future . <br>;Primary end point(s): -Assessment of 18F-PSMA PET-CT for detection of pancreatic adenocarcinoma in patients with clinically suspected or histological -proven resectable PDAC, prior to surgery (qualitative” visual evaluation). <br><br>;Timepoint(s) of evaluation of this end point: The PET-CT is performed prior to surgery. After resection of the pancreas, the tissue can be evaluated by histopathologic examination.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -The correlation between localisation 18F-PSMA uptake on PET-CT and PSMA expression in tissue using immunohistochemistry, and <br>-The identification of the lower limit of PSMA expression on tissue samples still resulting in detectable tumours (18F-PSMA positivity”) on the PET scan (quantitative” evaluation). This in order to select eligible patients for PSMA-based therapy in the future.;Timepoint(s) of evaluation of this end point: The PET-CT is performed prior to surgery. After resection of the pancreas, the tissue can be evaluated by histopathologic examination.