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Salivary Gland CancerADT-SCANNCT04214353

PSMA-PET Imaging Before and After ADT in Advanced SDC Patients

A study testing 68Ga-PSMA-PET/CT and 18FDG-PET/CT in people with Salivary Gland Cancer and Salivary Duct Carcinoma, run by Radboud University Medical Center at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
68Ga-PSMA-PET/CT and 18FDG-PET/CT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteNetherlands
Study dates
14 Jan 2020to Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Netherlands1 site, 1 recruiting

  • Radboudumc

    Nijmegen, Gelderland, 6500HB

    Carla ML van Herpen, MD, PhD, +31243613457, Carla.vanHerpen@radboudumc.nl

    Carla ML van Herpen, MD, PhD

    Recruiting

Other trials in Netherlands

About this study

Official title: Effect of Androgen Deprivation Therapy on Uptake of PSMA Ligand in Patients With Salivary Duct Carcinoma: an Explorative Study.

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.

Read the detailed description

Rationale: Prostate specific membrane antigen (PSMA) is a transmembrane protein, which is expressed on prostate cancers cells and other malignancies. Recently, several ligands have been developed that target PSMA. Linked to Gallium-68, this enables diagnostic 68Ga-PSMA-PET/CT scans. Linked to Lutetium-177 enables therapeutic 177Lu-PSMA Radioligand therapy. Most research on the diagnostic and therapeutic possibilities of PSMA has been conducted in patients with advanced prostate cancer.

This research group investigates whether these findings also apply to salivary gland cancer (SGC), a rare cancer. Previously the investigators conducted a phase II 68Ga-PSMA imaging study (NCT03319641), to evaluate PSMA ligand uptake in locally advanced, recurrent and metastatic ACC and SDC (two subtypes of SGC). A relevant PSMA-ligand uptake was observed in 93% of ACC patients and 40% of SDC patients. However, since 60% of SDC patients showed low ligand uptake, these patients are not suitable for PSMA radioligand therapy. For advanced SDC, androgen deprivation therapy is often given as first-line treatment, because the majority of SDCs are androgen receptor positive. In prostate cancer, androgen deprivation therapy (ADT) can increase PSMA-ligand uptake. Therefore the aim is to investigate if ADT can increase the uptake of 68Ga-PSMA in patients with R/M SDC, as has previously been demonstrated in prostate cancer.

Objective: The primary objective is to investigate if ADT can increase the uptake of 68Ga-PSMA in patients with R/M SDC.

Study design: Interventional clinical trial, an explorative study. Study population: Patients with locally advanced, recurrent or metastatic (R/M) SDC AR+ and who will start ADT as standard of care.

Being tested
68Ga-PSMA-PET/CT, 18FDG-PET/CT
Keywords
Positron-Emission Tomography, 68Ga-PSMA-PET/CT, 18FDG-PET/CT, Androgen deprivation therapy
Medical subject headings
Salivary Gland Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT04214353
Study groupRoleWhat they receive
Experimental armExperimentalSalivary 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.
Receives: Diagnostic Test: 68Ga-PSMA-PET/CT; Diagnostic Test: 18FDG-PET/CT

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Up to 4 weeks

Secondary outcomes (6)

  1. Change in 68Ga-PSMA uptake of tumor lesions

    Comparison of SUV (standardized uptake value) in 68Ga-PSMA PET/CT between lesions before and 3 weeks after the initiation of ADT (± 1 week).

    Measured: Up to 4 weeks

  2. Change in 18FDG uptake of tumor lesions

    Comparison of SUV (standardized uptake value) in 18FDG-PET/CT between lesions before and 3 weeks after the initiation of ADT (± 1 week).

    Measured: Up to 4 weeks

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

    The number of lesions detected on 68Ga-PSMA-PET/CT imaging will be measured, both before and after ADT.

    Measured: Up to 4 weeks

  4. FDG and PSMA uptake patterns of SDC disease

    FDG and PSMA uptake patterns of SDC disease on 68Ga-PSMA-PET/CT and 18FDG-PET/CT will be measured, e.g. to explore if most lesions show both FDG and PSMA uptake, or if the lesions show a more heterogenous uptake.

    Measured: Up to 4 weeks

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

    The number of lesions detected by each imaging modality (diagnostic CT, 68Ga-PSMA-PET/CT and 18FDG-PET/CT) will be measured.

    Measured: Up to 4 weeks

  6. Correlation PSMA expression and PSMA ligand uptake

    The tumor uptake (SUV) will be correlated to the degree of immunohistochemical PSMA expression on the most recent tumormaterial.

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2020
  2. Study start14 Jan 2020
  3. Primary completionMay 2023 (estimated)
  4. Study completionSep 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04214353
Sponsor's protocol ID
MOHN19
Acronym
ADT-SCAN
Status last verified
Aug 2022
First submitted
13 Dec 2019
Last updated
16 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 40663212

Questions about this trial

What is this clinical trial studying?

A study testing 68Ga-PSMA-PET/CT and 18FDG-PET/CT in people with Salivary Gland Cancer and Salivary Duct Carcinoma, run by Radboud University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients with a change in PSMA ligand uptake after ADT (time frame: Up to 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04214353, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2022.

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