Adenoid Cystic Carcinoma, Salivary Duct Carcinoma, Salivary Gland Cancer
Conditions
Keywords
68Ga-PSMA, Positron-Emission Tomography, Immunohistochemistry
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTPSMA-PET/CT scan
perform a PSMA-PET/CT scan in patients with locally advanced, recurrent and/or metastastic ACC or SDC
Sponsors
Adenoid Cystic Carcinoma Research Foundation
Radboud University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
diagnostic study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| uptake of 68Ga-PSMA in ACC and SDC | 0 days | To evaluate the uptake of 68Ga-PSMA in locally advanced, recurrent and metastatic ACC/SDC by performing 68Ga-PSMA-PET/CT scans |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| correlation of SUV and IHC PSMA-staining | 0 days | Correlate the tumor uptake (SUV) to the degree of immunohistochemical PSMA expression of the primary tumor on archival tissue |
| new metastases | 0 days | To establish whether new metastatic lesions are found by 68GA-PSMA-PET/CT imaging |
| SUV of 68Ga-PSMA in ACC/SDC tumors | 0 days | SUV of 68Ga-PSMA in ACC/SDC tumors |
| SUV of 68Ga-PSMA in the background | 0 days | in order to calculate the SUV tumor to background ratio |
Countries
Netherlands
Outcome results
None listed