Trial Title:
[18F]F-FAPI PET-CT to Identify Carcinoma of Unknown Primary Origin
NCT ID:
NCT06644716
Condition:
Cancer of Unknown Primary
Conditions: Official terms:
Carcinoma
Neoplasms, Unknown Primary
Conditions: Keywords:
[18F]F-FAPI
PET-CT
Cancer of Unknown Primary
Diagnostics
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
[18F]F-FAPI PET-CT
Description:
Each patient will receive a FAPI PET-CT.
Arm group label:
Patients with CUP
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.¬
Criteria for 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)
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Antoni van Leeuwenhoekziekenhuis
Address:
City:
Amsterdam
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
Serena Marchetti, MD, PhD
Phone:
0107042006
Email:
fapiforcup@erasmusmc.nl
Facility:
Name:
UMC Groningen
Address:
City:
Groningen
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
Michel van Kruchten, MD, PhD
Phone:
0107042006
Email:
fapiforcup@erasmusmc.nl
Facility:
Name:
Maastricht UMC
Address:
City:
Maastricht
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
Johanna Nin, MD, PhD
Phone:
0107042006
Email:
fapiforcup@erasmusmc.nl
Facility:
Name:
Radboud UMC
Address:
City:
Nijmegen
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
Anja Timmer-Bonte, MD, PhD
Phone:
0107042006
Email:
fapiforcup@erasmusmc.nl
Facility:
Name:
Erasmus Medical Center
Address:
City:
Rotterdam
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Sophie Veldhuijzen van Zanten, MD, PhD
Phone:
0107042006
Email:
fapiforcup@erasmusmc.nl
Facility:
Name:
UMC Utrecht
Address:
City:
Utrecht
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
Marnix Lam, MD, PhD
Phone:
0107042006
Email:
fapiforcup@erasmusmc.nl
Start date:
July 19, 2024
Completion date:
March 2027
Lead sponsor:
Agency:
Erasmus Medical Center
Agency class:
Other
Collaborator:
Agency:
Dutch Cancer Society
Agency class:
Other
Collaborator:
Agency:
Academisch Ziekenhuis Maastricht
Agency class:
Other
Collaborator:
Agency:
Missie Tumor Onbekend
Agency class:
Other
Collaborator:
Agency:
Noordwest Ziekenhuisgroep
Agency class:
Other
Collaborator:
Agency:
Cyclotron Noordwest BV
Agency class:
Other
Source:
Erasmus Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06644716
