[18F]F-FAPI PET-CT to Identify Carcinoma of Unknown Primary Origin

NCT06644716 | Recruiting

• 1 other identifier: 2023-505592-69-00
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 6

Brief Summary

The investigators will determine the proportion of CUP patients in whom the primary tumor can be identified by \[18F\]F-FAPI PET-CT.

Conditions

Cancer of Unknown Primary

Keywords

[18F]F-FAPI; PET-CT; Cancer of Unknown Primary; Diagnostics

Outcome Measures

Primary Outcomes (1)

• Detection of the primary tumor by [18F]F-FAPI PET-CT

  The proportion of CUP patients in whom the primary tumor can be identified by \[18F\]F-FAPI PET-CT

  2 years

Secondary Outcomes (1)

• Sensitivity, specificity, positive- and negative predictive value of [18F]F-FAPI PET-CT

  2 years

Study Arms (1)

Patients with CUP

EXPERIMENTAL

Patients diagnosed with CUP after standard diagnostic work-up including an \[18F\]FDG PET-CT

Diagnostic Test: [18F]F-FAPI PET-CT

Interventions

[18F]F-FAPI PET-CT DIAGNOSTIC_TEST

Each patient will receive a FAPI PET-CT.

Patients with CUP

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• Histologically-confirmed metastatic disease without identification of a primary tumor after standard diagnostic work-up, according to the national care pathway for CUP (in Dutch: Regionaal Zorgpad Primaire Tumor Onbekend), which includes at least an \[18F\]FDG PET-CT.

You may not qualify if:

• Patients with metastasis from a known primary tumor.
• Sarcomas, melanomas, germ cell tumors, neuroendocrine tumors and haematological malignancies whose exact site of origin is not established.
• History of malignancy within 5 years prior to \[18F\]F-FAPI PET-CT scan, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \> 90%), such as adequately treated carcinoma in-situ of the cervix, nonmelanoma skin carcinoma, localized prostate cancer, ductal carcinoma in-situ, or Stage I uterine cancer.
• Prior systemic therapy for the treatment of CUP.
• Radiotherapy prior to \[18F\]F-FAPI PET-CT. Off note: radiotherapy with palliative intent for symptomatic skeleton lesions is allowed.
• Impaired renal function, defined as eGFR (MDRD) \<25 ml/min/1,73 m2. An exception can be made in consultation with the treating physician.
• WHO performance status \>2 (Vademecum).
• Pregnancy/breastfeeding. For the latter, temporary discontinuation may be considered.
• Known allergic reaction to therapeutic radiopharmaceuticals
• Inability to lie still on the back for the duration of PET-CT
• Any (other) condition, disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that may affect the interpretation of the results, or which might contribute substantially to the patient's experience of study burden (such as non-suppressible claustrophobia)

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Dutch Cancer Society: collaborator
• Academisch Ziekenhuis Maastricht: collaborator
• Missie Tumor Onbekend: collaborator
• Noordwest Ziekenhuisgroep: collaborator
• Cyclotron Noordwest BV: collaborator

Study Sites (6)

Antoni van Leeuwenhoekziekenhuis

Amsterdam, Netherlands

RECRUITING

UMC Groningen

Groningen, Netherlands

RECRUITING

Maastricht UMC

Maastricht, Netherlands

RECRUITING

Radboud UMC

Nijmegen, Netherlands

RECRUITING

Erasmus Medical Center

Rotterdam, Netherlands

RECRUITING

UMC Utrecht

Utrecht, Netherlands

RECRUITING

Study Officials

• Sophie Veldhuijzen van Zanten

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie Veldhuijzen van Zanten, MD, PhD

CONTACT

0107042006; fapiforcup@erasmusmc.nl

Esther Droogers

CONTACT

0107042006; e.droogers@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 16, 2024
• Study Start: July 19, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months and ending 5 years after publication of the main results.
• Access Criteria: Investigators who provide a sound proposal which has been approved by a review committee.

Locations

NL (6)