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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
25
perform a PSMA-PET/CT scan in patients with locally advanced, recurrent and/or metastastic ACC or SDC
Radboudumc
Nijmegen, Gelderland, Netherlands
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
Time frame: 0 days
SUV of 68Ga-PSMA in ACC/SDC tumors
SUV of 68Ga-PSMA in ACC/SDC tumors
Time frame: 0 days
SUV of 68Ga-PSMA in the background
in order to calculate the SUV tumor to background ratio
Time frame: 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
Time frame: 0 days
new metastases
To establish whether new metastatic lesions are found by 68GA-PSMA-PET/CT imaging
Time frame: 0 days
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