68Ga-PSMA-PET/CT imaging for locally advanced, recurrent and metastatic adenoid cystic carcinoma or salivary duct carcinoma

Completed

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

• Registration Number: NL-OMON44299
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

- locally advanced, recurrent or metastatic ACC or SDC
- Age * 18 years old
- Ability to provide written informed consent

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 * 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>Primary objective<br /><br>- To evaluate the uptake of 68Ga-PSMA in locally advanced, recurrent and<br /><br>metastatic ACC or SDC by performing 68Ga-PSMA-PET/CT scans.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives<br /><br>- To calculate the SUV tumor-to-background ratio and tumor-to-*healthy salivary<br /><br>gland tissue* ratio.<br /><br>- Correlate the tumor uptake (SUV) to the degree of immunohistochemical PSMA<br /><br>expression of the primary tumor on archival tissue or a fresh biopsy.<br /><br>- To establish whether new metastatic lesions are found by 68GA-PSMA-PET/CT<br /><br>imaging.</p><br>