NCT04214353

Brief Summary

Explorative study, which evaluates the effect of androgen deprivation therapy (ADT) on the PSMA ligand uptake on 68Ga-PSMA-PET/CT in salivary duct carcinoma patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

December 13, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

January 14, 2020

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

August 16, 2022

Status Verified

August 1, 2022

Enrollment Period

3.3 years

First QC Date

December 13, 2019

Last Update Submit

August 15, 2022

Conditions

Salivary Gland CancerSalivary Duct Carcinoma

Keywords

Positron-Emission Tomography68Ga-PSMA-PET/CT18FDG-PET/CTAndrogen deprivation therapy

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients with a change in PSMA ligand uptake after ADT

    The percentage of patients with an androgen deprivation therapy (ADT) induced change in PSMA ligand uptake on 68Ga-PSMA-PET/CT. pre-scan: baseline (before ADT), post-scan: 3 weeks after start ADT (± 1 week).

    Up to 4 weeks

Secondary Outcomes (6)

  • Change in 68Ga-PSMA uptake of tumor lesions

    Up to 4 weeks

  • Change in 18FDG uptake of tumor lesions

    Up to 4 weeks

  • Lesions detected by 68Ga-PSMA-PET/CT pre- and post ADT

    Up to 4 weeks

  • FDG and PSMA uptake patterns of SDC disease

    Up to 4 weeks

  • Diagnostic added value 68Ga-PSMA-PET/CT and 18FDG-PET/CT.

    Up to 4 weeks

  • +1 more secondary outcomes

Study Arms (1)

Experimental arm

EXPERIMENTAL

Salivary duct carcinoma patients with R/M disease, who will start androgen deprivation therapy as standard of care will receive PET/CT scans before and after ADT.

Diagnostic Test: 68Ga-PSMA-PET/CTDiagnostic Test: 18FDG-PET/CT

Interventions

68Ga-PSMA-PET/CTDIAGNOSTIC_TEST

All participants in the study will be injected with 2.0 MBq/kg 68Ga-PSMA for PET/CT imaging, both pre- and post ADT.

Experimental arm
18FDG-PET/CTDIAGNOSTIC_TEST

All participants in the study will be injected with 2.1 MBq/kg 18FDG for PET/CT imaging, both pre- and post ADT.

Experimental arm

Eligibility Criteria

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

You may qualify if:

  • Patients must have the ability to provide written informed consent.
  • Patients must be ≥ 18 years of age.
  • Patients must have histological, pathological, and/or cytological confirmation of salivary duct carcinoma, androgen receptor positive.
  • Only patients with locally advanced, recurrent or metastatic salivary duct carcinoma can participate.
  • Patients must have at least one lesion with a diameter of ≥ 1.5 cm.
  • Patients whom intend to start androgen deprivation therapy, after this has been recommended by the treating physician as standard treatment.

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 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

RECRUITING

Related Publications (1)

  • van Ruitenbeek NJ, Uijen MJM, Driessen CML, van Rijk MC, Peters SMB, Prive BM, Verhaegh GW, van Engen-van Grunsven ACH, Gotthardt M, Nagarajah J, van Herpen CML. The effect of androgen blockade on [68Ga]Ga-PSMA-11 and [18F]FDG PET uptake in patients with recurrent or metastatic salivary duct carcinoma: a prospective imaging study. EJNMMI Res. 2025 Jul 15;15(1):86. doi: 10.1186/s13550-025-01275-x.

    PMID: 40663212DERIVED

MeSH Terms

Conditions

Salivary Gland Neoplasms

Condition Hierarchy (Ancestors)

Mouth NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2019

First Posted

January 2, 2020

Study Start

January 14, 2020

Primary Completion

May 1, 2023

Study Completion

September 1, 2023

Last Updated

August 16, 2022

Record last verified: 2022-08

Locations

NL(1)