Clinical trial · Interventional
PSMA-PET Imaging Before and After ADT in Advanced SDC Patients
Effect of Androgen Deprivation Therapy on Uptake of PSMA Ligand in Patients With Salivary Duct Carcinoma: an Explorative Study.
NCT04214353CI-TRIAL-00060359ADT-SCANunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Explorative study, which evaluates the effect of androgen deprivation therapy (ADT) on the PSMA ligand uptake on 68Ga-PSMA-PET/CT in salivary duct carcinoma patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Salivary Duct Carcinoma | Salivary Duct Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Salivary Gland Cancer | Malignant Salivary Gland Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18FDG-PET/CT | Diagnostic Test | — | UNRESOLVED |
| 68Ga-PSMA-PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental arm
- description
- Salivary duct carcinoma patients with R/M disease, who will start androgen deprivation therapy as standard of care will receive PET/CT scans before and after ADT.
- interventionNames
- Diagnostic Test: 68Ga-PSMA-PET/CT
- Diagnostic Test: 18FDG-PET/CT
Primary outcomes (1)
- measure
- Percentage of patients with a change in PSMA ligand uptake after ADT
- timeFrame
- Up to 4 weeks
- description
- The percentage of patients with an androgen deprivation therapy (ADT) induced change in PSMA ligand uptake on 68Ga-PSMA-PET/CT. pre-scan: baseline (before ADT), post-scan: 3 weeks after start ADT (± 1 week).
Secondary outcomes (6)
- measure
- Change in 68Ga-PSMA uptake of tumor lesions
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have the ability to provide written informed consent. * Patients must be ≥ 18 years of age. * Patients must have histological, pathological, and/or cytological confirmation of salivary duct carcinoma, androgen receptor positive. * Only patients with locally advanced, recurrent or metastatic salivary duct carcinoma can participate. * Patients must have at least one lesion with a diameter of ≥ 1.5 cm. * Patients whom intend to start androgen deprivation therapy, after this has been recommended by the treating physician as standard treatment. Exclusion Criteria: * Contra-indication for PET imaging (pregnancy, breast feeding severe claustrophobia) * Impaired renal function: MDRD \<30 ml/min/1,73 m2 * Impaired liver function: AST and ALT ALT ≥ 2.5 x ULN (≥5 x ULN for patients with liver metastases)
References
Publications (1)
- DERIVEDvan Ruitenbeek NJ, Uijen MJM, Driessen CML, van Rijk MC, Peters SMB, Prive BM, Verhaegh GW, van Engen-van Grunsven ACH, Gotthardt M, Nagarajah J, van Herpen CML. The effect of androgen blockade on [68Ga]Ga-PSMA-11 and [18F]FDG PET uptake in patients with recurrent or metastatic salivary duct carcinoma: a prospective imaging study. EJNMMI Res. 2025 Jul 15;15(1):86. doi: 10.1186/s13550-025-01275-x. PMID 40663212