NCT03319641

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2017

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 24, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

October 25, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2018

Completed
Last Updated

May 30, 2018

Status Verified

May 1, 2018

Enrollment Period

7 months

First QC Date

September 29, 2017

Last Update Submit

May 28, 2018

Conditions

Salivary Gland CancerAdenoid Cystic CarcinomaSalivary Duct Carcinoma

Keywords

68Ga-PSMAPositron-Emission TomographyImmunohistochemistry

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • SUV of 68Ga-PSMA in ACC/SDC tumors

    0 days

  • SUV of 68Ga-PSMA in the background

    0 days

  • correlation of SUV and IHC PSMA-staining

    0 days

  • new metastases

    0 days

Study Arms (1)

PSMA-PET/CT scan

EXPERIMENTAL

PSMA-PET/CT imaging in advanced ACC/SDC

Diagnostic Test: PSMA-PET/CT scan

Interventions

PSMA-PET/CT scanDIAGNOSTIC_TEST

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

PSMA-PET/CT scan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • locally advanced, recurrent or metastatic ACC/SDC
  • Age ≥ 18 years old
  • Ability to provide written informed consent

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6500HB, Netherlands

Location

MeSH Terms

Conditions

Salivary Gland NeoplasmsCarcinoma, Adenoid Cystic

Condition Hierarchy (Ancestors)

Mouth NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Carla ML van Herpen, MD, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: diagnostic study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 29, 2017

First Posted

October 24, 2017

Study Start

October 25, 2017

Primary Completion

May 14, 2018

Study Completion

May 14, 2018

Last Updated

May 30, 2018

Record last verified: 2018-05

Locations

NL(1)