Effect of androgen deprivation therapy on uptake of PSMA ligand in patients with salivary duct carcinoma: an explorative study.

Recruiting

• Conditions: salivary duct carcinoma; salivary gland cancer; 10027656

• Registration Number: NL-OMON48488
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 14

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 re-commended by the treating physician as standard treatment.

Exclusion Criteria

• Contra-indication for PET imaging: pregnancy or breast feeding or 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)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The percentage of patients with an ADT induced increase in PSMA ligand uptake<br /><br>on 68Ga-PSMA-PET/CT. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- standardised uptake values (SUV) of recurrence and/or metastases in<br /><br>68Ga-PSMA-PET/CT pre- and post ADT.<br /><br>- standardised uptake values of recurrence and/or metastases in 18FDG-PET/CT<br /><br>pre- and post ADT.<br /><br>- correlation between SUV and the degree of immunohistochemical PSMA<br /><br>expression.</p><br>