PSMA-PET Imaging for Advanced ACC/SDC
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|ClinicalTrials.gov Identifier: NCT03319641|
Recruitment Status : Completed
First Posted : October 24, 2017
Last Update Posted : May 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Salivary Gland Cancer Adenoid Cystic Carcinoma Salivary Duct Carcinoma||Diagnostic Test: PSMA-PET/CT scan||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||diagnostic study|
|Masking:||None (Open Label)|
|Official Title:||68Ga-PSMA-PET/CT Imaging for Locally Advanced, Recurrent and Metastatic Adenoid Cystic Carcinoma or Salivary Duct Carcinoma|
|Actual Study Start Date :||October 25, 2017|
|Actual Primary Completion Date :||May 14, 2018|
|Actual Study Completion Date :||May 14, 2018|
Experimental: PSMA-PET/CT scan
PSMA-PET/CT imaging in advanced ACC/SDC
Diagnostic Test: PSMA-PET/CT scan
perform a PSMA-PET/CT scan in patients with locally advanced, recurrent and/or metastastic ACC or SDC
- uptake of 68Ga-PSMA in ACC and SDC [ Time Frame: 0 days ]To evaluate the uptake of 68Ga-PSMA in locally advanced, recurrent and metastatic ACC/SDC by performing 68Ga-PSMA-PET/CT scans
- SUV of 68Ga-PSMA in ACC/SDC tumors [ Time Frame: 0 days ]SUV of 68Ga-PSMA in ACC/SDC tumors
- SUV of 68Ga-PSMA in the background [ Time Frame: 0 days ]in order to calculate the SUV tumor to background ratio
- correlation of SUV and IHC PSMA-staining [ Time Frame: 0 days ]Correlate the tumor uptake (SUV) to the degree of immunohistochemical PSMA expression of the primary tumor on archival tissue
- new metastases [ Time Frame: 0 days ]To establish whether new metastatic lesions are found by 68GA-PSMA-PET/CT imaging
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03319641
|Nijmegen, Gelderland, Netherlands, 6500HB|
|Principal Investigator:||Carla ML van Herpen, MD, PhD||Radboud University|