18F-Prostate Specific Membrane Antigen PET-CT as a potential novel imaging modality for pancreatic cancer: A pilot study (PANSCAN-2)

Phase 2

Recruiting

• Conditions: pancreas carcinoma; pancreatic cancer; 10015674

• Registration Number: NL-OMON52415
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2024-02-27
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• 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.

Exclusion Criteria

- Patients with metastatic PC 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.
- Unacceptable known (clinically significant) cardiovascular or pulmonary
disease, renal or liver dysfunction, which could hamper participation in this
study or jeopardize the patients* health.
- 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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint: feasibility of 18F-PSMA PET-CT for detection of pancreatic<br /><br>adenocarcinoma in patients with clinically suspected or histological -proven<br /><br>resectable PC, prior to surgery (*qualitative* visual evaluation).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints: (1) the correlation between localisation 18F-PSMA uptake<br /><br>on PET-CT and PSMA expression in tissue using immunohistochemistry, and (2) the<br /><br>identification of the lower limit of PSMA expression on tissue samples still<br /><br>resulting in detectable tumours (18F-PSMA *positivity*) on the PET scan<br /><br>(*quantitative* evaluation). This in order to select eligible patients for<br /><br>PSMA-based therapy in the future.</p><br>