PSMA-PET Imaging for Advanced ACC/SDC

May 28, 2018 updated by: Carla van Herpen, Radboud University Medical Center

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500HB
        • Radboudumc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Adenoid Cystic Carcinoma Research Foundation

Investigators

  • Principal Investigator: Carla ML van Herpen, MD, PhD, Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2017

Primary Completion (Actual)

May 14, 2018

Study Completion (Actual)

May 14, 2018

Study Registration Dates

First Submitted

September 29, 2017

First Submitted That Met QC Criteria

October 19, 2017

First Posted (Actual)

October 24, 2017

Study Record Updates

Last Update Posted (Actual)

May 30, 2018

Last Update Submitted That Met QC Criteria

May 28, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 104902 (GSK)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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