PSMA-PET Imaging for Advanced ACC/SDC

Study Overview
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Brief Summary
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Diagnostic study which evaluates the level of PSMA expression in patients with locally advanced, recurrent and/or metastatic ACC/SDC of ≥18 years old with 68Ga-PSMA-PET/CT imaging in order to establish whether these patients are eligible for 177Lu-PSMA therapy

Detailed Description
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Rationale: PSMA is a transmembrane protein, which is expressed on prostate cancers cells, ACC and other malignancies. In prostate cancer, distant metastases can be visualized sensitively and non-invasively with 68Ga-PSMA-PET/CT scans and if the uptake of 68Ga is high enough, patients can be treated with the β-emitting radionuclide 177Lu-PSMA. In the current study, we will evaluate the uptake of 68Ga-PSMA by performing 68Ga-PSMA-PET/CT scans in advanced ACC and SDC patients. If the uptake is high enough, this will form the rationale for a therapeutic study with 177Lu-PSMA in ACC and SDC. Objective: The primary objective is to evaluate the uptake of 68Ga-PSMA in locally advanced, recurrent and metastatic ACC/SDC by performing 68Ga-PSMA-PET/CT scans. The secondary objectives are to calculate the SUV tumor-to-background ratio and tumor-to-'healthy salivary gland tissue' ratio. To correlate the SUV to the degree of immunohistochemical PSMA expression of the primary tumor on archival tissue, and to establish whether new metastatic lesions are found by 68GA-PSMA-PET/CT imaging. Study design: Diagnostic study which evaluates the level of PSMA expression in ACC/SDC patients with 68Ga-PSMA-PET/CT imaging in order to establish whether these patients are eligible for 177Lu-PSMA therapy. Study population: Patients with locally advanced, recurrent or metastatic ACC/SDC of ≥18 years old.

Official Title
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68Ga-PSMA-PET/CT Imaging for Locally Advanced, Recurrent and Metastatic Adenoid Cystic Carcinoma or Salivary Duct Carcinoma

Conditions
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Salivary Gland Cancer, Adenoid Cystic Carcinoma, Salivary Duct Carcinoma

Intervention / Treatment
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* Diagnostic Test: PSMA-PET/CT scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: locally advanced, recurrent or metastatic ACC/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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: diagnostic study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PSMA-PET/CT scan<br>PSMA-PET/CT imaging in advanced ACC/SDC | Diagnostic Test: PSMA-PET/CT scan<br>* perform a PSMA-PET/CT scan in patients with locally advanced, recurrent and/or metastastic ACC or SDC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| uptake of 68Ga-PSMA in ACC and SDC | To evaluate the uptake of 68Ga-PSMA in locally advanced, recurrent and metastatic ACC/SDC by performing 68Ga-PSMA-PET/CT scans | 0 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SUV of 68Ga-PSMA in ACC/SDC tumors | SUV of 68Ga-PSMA in ACC/SDC tumors | 0 days | 
| SUV of 68Ga-PSMA in the background | in order to calculate the SUV tumor to background ratio | 0 days | 
| correlation of SUV and IHC PSMA-staining | Correlate the tumor uptake (SUV) to the degree of immunohistochemical PSMA expression of the primary tumor on archival tissue | 0 days | 
| new metastases | To establish whether new metastatic lesions are found by 68GA-PSMA-PET/CT imaging | 0 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Positron-Emission Tomography, 68Ga-PSMA, Immunohistochemistry