Actively Recruiting
[18F]F-FAPI PET-CT to Identify Carcinoma of Unknown Primary Origin
Led by Erasmus Medical Center · Updated on 2025-02-12
50
Participants Needed
6
Research Sites
30 weeks
Total Duration
On this page
Sponsors
E
Erasmus Medical Center
Lead Sponsor
D
Dutch Cancer Society
Collaborating Sponsor
AI-Summary
What this Trial Is About
Carcinoma of unknown primary origin (CUP) is a group of cancers where metastatic disease is present but the original tumor cannot be found despite extensive tests. This condition limits treatment options since therapies often target known primary tumors. Researchers are evaluating whether a new imaging test called [18F]F-fluoro fibroblast activation protein inhibitor (F-FAPI) PET-CT can detect the primary tumor in patients diagnosed with CUP after standard diagnostic scans including FDG PET-CT. This multi-center, prospective clinical study involves 50 adult patients with CUP to better understand the usefulness of this new scan method. Each participant will undergo a single [18F]F-FAPI PET-CT scan at one of the six study centers. Images from this scan will be centrally reviewed and shared with the treating doctor, who may recommend further tests or treatments based on the findings. After six months, results from the F-FAPI PET-CT will be compared with clinical, radiological, and pathological follow-up data. A multidisciplinary panel will then review all information to decide how valuable the [18F]F-FAPI PET-CT is for identifying the primary tumor in CUP patients. Participants will be involved in one main scanning visit and followed for six months through routine clinical assessments. The study team will monitor detection of the primary tumor using the new scan as the main outcome, and also assess the test’s accuracy measures like sensitivity and specificity. Participation requires being able to undergo the scan and complete follow-up, with the entire process lasting about two years for outcome measurement. This study is sponsored by Erasmus Medical Center.
CONDITIONS
Brief Title
[18F]F-FAPI PET-CT to Identify Carcinoma of Unknown Primary Origin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed metastatic disease with no identified primary tumor after standard diagnostic work-up including at least an [18F]FDG PET-CT
You will not qualify if you...
- Patients with metastasis from a known primary tumor
- Sarcomas, melanomas, germ cell tumors, neuroendocrine tumors, and hematological malignancies without established origin
- History of malignancy within 5 years prior to [18F]F-FAPI PET-CT scan, except the cancer under study or low-risk cancers such as 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 CUP
- Radiotherapy prior to [18F]F-FAPI PET-CT, except palliative radiotherapy for symptomatic bone lesions
- Impaired renal function with eGFR <25 ml/min/1.73 m2 unless approved by physician
- WHO performance status greater than 2
- Pregnancy or breastfeeding (temporary discontinuation may be considered for breastfeeding)
- Known allergy to therapeutic radiopharmaceuticals
- Inability to lie still on back during PET-CT
- Any condition that may affect scan results or increase study burden such as severe claustrophobia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants undergo a one-time [18F]F-FAPI PET-CT examination to detect the primary tumor.
1 visit (in-person)
Duration - 6 months
Participants are followed for 6 months to compare PET-CT results with clinical, radiological, and pathological outcomes.
Follow-up assessments as part of routine clinical care
Trial Site Locations
Total: 6 locations
1
Antoni van Leeuwenhoekziekenhuis
Amsterdam, Netherlands
Actively Recruiting
2
UMC Groningen
Groningen, Netherlands
Actively Recruiting
3
Maastricht UMC
Maastricht, Netherlands
Actively Recruiting
4
Radboud UMC
Nijmegen, Netherlands
Actively Recruiting
5
Erasmus Medical Center
Rotterdam, Netherlands
Actively Recruiting
6
UMC Utrecht
Utrecht, Netherlands
Actively Recruiting
Research Team
S
Sophie Veldhuijzen van Zanten, MD, PhD
E
Esther Droogers
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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