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

NCT ID: NCT06644716

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-19
• Study Completion Date: 2027-03-31

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.

Detailed Description

Carcinoma of unknown primary origin (CUP) is a diverse group of cancers defined by the presence of metastatic disease with no identified primary tumor after exhaustive diagnostic work-up. Absence of a known targetable primary tumor precludes patients from receiving tumor-specific evidence-based therapies which significantly impacts the life expectancy of CUP patients. In this investigator-initiated and patient association-driven, multi-center, prospective clinical study we aim to detect the primary tumor by PET-CT using the novel radiotracer [18F]F-fluoro fibroblast activation protein inhibitor (F-FAPI). We will include 50 patients (aged >18 year) who have been diagnosed with CUP after standard diagnostic work-up including FDG PET-CT. Participation in the study entails a one-time [18F]F-FAPI PET-CT examination in one of the six study centers (UMC Groningen, UMC Utrecht, Antoni van Leeuwenhoek, Radboudumc, Maastricht UMC, Erasmus MC). For the interpretation of images, central reading will be performed and results will be made available to the treating physician with an accompanying recommendation for additional diagnostics and/or treatment. After 6 months, the results of the [18F]F-FAPI PET-CT will be compared with patient follow up, including clinical, radiological and pathological outcome parameters. These findings will holistically be discussed in a multidisciplinary Truth Panel meeting to determine a uniform verdict with regard to the clinical value of [18F]F-FAPI for CUP. We hypothesize that [18F]F-FAPI PET-CT will detect the primary tumor in at least 15% of our CUP patients.¬

Conditions

Cancer of Unknown Primary

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients with CUP

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

Group Type: EXPERIMENTAL

[18F]F-FAPI PET-CT

Intervention Type: DIAGNOSTIC_TEST

Each patient will receive a FAPI PET-CT.

Interventions

[18F]F-FAPI PET-CT

Each patient will receive a FAPI PET-CT.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dutch Cancer Society

OTHER

Sponsor Role: collaborator

Academisch Ziekenhuis Maastricht

OTHER

Sponsor Role: collaborator

Missie Tumor Onbekend

UNKNOWN

Sponsor Role: collaborator

Noordwest Ziekenhuisgroep

OTHER

Sponsor Role: collaborator

Cyclotron Noordwest BV

UNKNOWN

Sponsor Role: collaborator

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Dr. S.E.M. Veldhuijzen van Zanten

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sophie Veldhuijzen van Zanten

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

Antoni van Leeuwenhoekziekenhuis

Amsterdam, , Netherlands

Site Status: RECRUITING

UMC Groningen

Groningen, , Netherlands

Site Status: RECRUITING

Maastricht UMC

Maastricht, , Netherlands

Site Status: RECRUITING

Radboud UMC

Nijmegen, , Netherlands

Site Status: RECRUITING

Erasmus Medical Center

Rotterdam, , Netherlands

Site Status: RECRUITING

UMC Utrecht

Utrecht, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Sophie Veldhuijzen van Zanten, MD, PhD

Role: CONTACT

fapiforcup@erasmusmc.nl

0107042006

Esther Droogers

Role: CONTACT

e.droogers@erasmusmc.nl

0107042006

Facility Contacts

Serena Marchetti, MD, PhD

Role: primary

fapiforcup@erasmusmc.nl

0107042006

Michel van Kruchten, MD, PhD

Role: primary

fapiforcup@erasmusmc.nl

0107042006

Johanna Nin, MD, PhD

Role: primary

fapiforcup@erasmusmc.nl

0107042006

Anja Timmer-Bonte, MD, PhD

Role: primary

fapiforcup@erasmusmc.nl

0107042006

Sophie Veldhuijzen van Zanten, MD, PhD

Role: primary

fapiforcup@erasmusmc.nl

0107042006

Marnix Lam, MD, PhD

Role: primary

fapiforcup@erasmusmc.nl

0107042006

Other Identifiers

2023-505592-69-00

Identifier Type: -

Identifier Source: org_study_id