Clinical trial NCT03319641: PSMA-PET Imaging for Advanced ACC/SDC
Official title: 68Ga-PSMA-PET/CT Imaging for Locally Advanced, Recurrent and Metastatic Adenoid Cystic Carcinoma or Salivary Duct Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Salivary Gland Cancer
Adenoid Cystic Carcinoma
Salivary Duct Carcinoma
Keywords: 68Ga-PSMA
Positron-Emission Tomography
Immunohistochemistry
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Adenoid Cystic Carcinoma Research Foundation
First posted: 2017-10-24
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: diagnostic study
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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)

Primary outcomes:
measure: uptake of 68Ga-PSMA in ACC and SDC
timeFrame: 0 days
Secondary outcomes:
measure: SUV of 68Ga-PSMA in ACC/SDC tumors
timeFrame: 0 days
measure: SUV of 68Ga-PSMA in the background
timeFrame: 0 days
measure: correlation of SUV and IHC PSMA-staining
timeFrame: 0 days
measure: new metastases
timeFrame: 0 days
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Carla ML van Herpen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: