Ignite Creation Date:
2024-10-25 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06644716
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-04
Brief Title:
18FF-FAPI PET-CT to Identify Carcinoma of Unknown Primary Origin
Sponsor:
None
Organization:
None
Study Overview
Official Title:
18FF-FAPI PET-CT to Identify Carcinoma of Unknown Primary Origin
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FAPI for CUP
Brief Summary:
The investigators will determine the proportion of CUP patients in whom the primary tumor can be identified by 18FF-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 18FF-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 18FF-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 andor treatment After 6 months the results of the 18FF-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 18FF-FAPI for CUP We hypothesize that 18FF-FAPI PET-CT will detect the primary tumor in at least 15 of our CUP patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None