PSMA-PET Imaging for Advanced ACC/SDC

Adenoid Cystic Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03319641
• Other study ID #: 104902
• Status: Completed
• Phase: N/A
• Start date: October 25, 2017
• Est. completion date: May 14, 2018

Study information

• Verified date: May 2018
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 14, 2018
• Est. primary completion date: May 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Adenoid Cystic Carcinoma
• Carcinoma
• Carcinoma, Adenoid Cystic
• Carcinoma, Ductal
• Salivary Duct Carcinoma
• Salivary Gland Cancer
• Salivary Gland Neoplasms

Intervention

Diagnostic Test:
• PSMA-PET/CT scan
perform a PSMA-PET/CT scan in patients with locally advanced, recurrent and/or metastastic ACC or SDC

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Adenoid Cystic Carcinoma Research Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	SUV of 68Ga-PSMA in ACC/SDC tumors	SUV of 68Ga-PSMA in ACC/SDC tumors	0 days
Secondary	SUV of 68Ga-PSMA in the background	in order to calculate the SUV tumor to background ratio	0 days
Secondary	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
Secondary	new metastases	To establish whether new metastatic lesions are found by 68GA-PSMA-PET/CT imaging	0 days