This study has been transitioned to CTIS with ID 2024-518838-82-00 check the CTIS register for the current data. To evaluate if a combination of FAPI-PET/CT and FDG-PET/CT scan is able to detect active fibroblast tissue and inflammation in patients…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Benigne fibroblast vorming in de Tunica Albuginea van de penis bij mannen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Detection of active fibroblasts (uptake of FAPI) and/or inflammation (uptake of
FDG) in the penis of PD patients with FAPI-PET/CT scan and FDG-PET/CT scan.
Secondary outcome
none
Background summary
Peyronie*s Disease (PD) causes curvature of the penis due to continuous grow of
fibroblasts, leading to an inflammatory reaction in the Tunica Albuginea, and
causing pain in the acute phase in 20-70% of men. New pharmaceutical therapies
are developed, but these are only suitable for the active phase. It is
difficult to differentiate between the active phase with inflammation and
active fibrosis, and the chronic phase with end stage fibrosis. At this moment,
this differentiation can only be done by the history of the patient and
physical examination.
Having a diagnostic test that is able to distinguish between the active and
chronic phase will be ground-breaking and will support the decision to
prescribe the new pharmaceutical options in the future.
FAPI-PET/CT scan is able to show active fibroblasts in tumour tissue. Recent
studies also showed that this imaging technique is able to detect active
fibroblasts in benign diseases, like idiopathic retroperitoneal fibrosis.
FDG-PET/CT scan can visualise active fibroblasts and inflammation based on
enhanced uptake of glucose inside the fibroblasts and other inflammatory cells.
Study objective
This study has been transitioned to CTIS with ID 2024-518838-82-00 check the CTIS register for the current data.
To evaluate if a combination of FAPI-PET/CT and FDG-PET/CT scan is able to
detect active fibroblast tissue and inflammation in patients with acute phase
Peyronie's Disease.
Study design
Pilot study
Study burden and risks
Extra radiation through the PET/CT scans.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
painful erections
onset for <6 months
palpable nodule men > 18 years of age
Mentally competent and understanding of benefits and potential burden of the
study
Be able to sign written infromed consent read and understand Dutch
Exclusion criteria
Known other malignant disease
previous treatment for Peyronie's disease
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2024-518838-82-00 |
| EudraCT | EUCTR2022-002770-82-NL |
| CCMO | NL81707.042.22 |