Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 28 of 128 for:    Adenoid Cystic Carcinoma

PSMA-PET Imaging for Advanced ACC/SDC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03319641
Recruitment Status : Completed
First Posted : October 24, 2017
Last Update Posted : May 30, 2018
Sponsor:
Collaborator:
Adenoid Cystic Carcinoma Research Foundation
Information provided by (Responsible Party):
Carla van Herpen, Radboud University

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

Condition or disease Intervention/treatment Phase
Salivary Gland Cancer Adenoid Cystic Carcinoma Salivary Duct Carcinoma Diagnostic Test: PSMA-PET/CT scan Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Intervention Model Description: diagnostic study
Masking: None (Open Label)
Primary Purpose: Diagnostic
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


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. SUV of 68Ga-PSMA in ACC/SDC tumors [ Time Frame: 0 days ]
    SUV of 68Ga-PSMA in ACC/SDC tumors

  2. SUV of 68Ga-PSMA in the background [ Time Frame: 0 days ]
    in order to calculate the SUV tumor to background ratio

  3. 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

  4. new metastases [ Time Frame: 0 days ]
    To establish whether new metastatic lesions are found by 68GA-PSMA-PET/CT imaging



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

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


Locations
Layout table for location information
Netherlands
Radboudumc
Nijmegen, Gelderland, Netherlands, 6500HB
Sponsors and Collaborators
Radboud University
Adenoid Cystic Carcinoma Research Foundation
Investigators
Layout table for investigator information
Principal Investigator: Carla ML van Herpen, MD, PhD Radboud University
  Study Documents (Full-Text)

Documents provided by Carla van Herpen, Radboud University:

Layout table for additonal information
Responsible Party: Carla van Herpen, MD, PhD, Radboud University
ClinicalTrials.gov Identifier: NCT03319641     History of Changes
Other Study ID Numbers: 104902
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carla van Herpen, Radboud University:
68Ga-PSMA
Positron-Emission Tomography
Immunohistochemistry
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Adenoid Cystic
Carcinoma, Ductal
Salivary Gland Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases
Salivary Gland Diseases
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary