NCT05581979

Brief Summary

The objectives of this pilot feasibility study, which is on the use of 68-Ga PSMA PET imaging of salivary gland tumours, are

  • to determine the proportion of patients with high PSMA-ligand uptake on Ga-68 PSMA imaging in locally advanced, recurrent or metastatic salivary gland cancers and other rare cancer; and
  • to determine if in vitro PSMA expression correlates to PSMA-ligand uptake on Ga-68 PSMA imaging in locally advanced, recurrent or metastatic salivary gland cancers and other rare cancers. The hypotheses of this study are that there is high PSMA-ligand uptake on Ga-68 PSMA imaging in locally advanced, recurrent or metastatic salivary gland cancers and other rare cancers; and that in vitro PSMA expression correlates to PSMA-ligand uptake on Ga-68 PSMA imaging.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2022

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

Study Start

First participant enrolled

January 26, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 17, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

July 25, 2025

Status Verified

July 1, 2025

Enrollment Period

1.3 years

First QC Date

September 28, 2022

Last Update Submit

July 24, 2025

Conditions

Salivary Gland TumorRare Malignant Neoplasm

Keywords

68-Ga PSMA PET ImagingSalivary GlandRadiolabelingGallium-68PET scanProstate Specific Membrane AntigenAdenocystic CarcinomaRare Tumours

Outcome Measures

Primary Outcomes (1)

  • The proportion of patients with high PSMA-ligand uptake on Ga-68 PSMA imaging in locally advanced, recurrent or metastatic salivary gland cancers and other rare cancer.

    The proportion of patients with PSMA-ligand uptake greater than liver uptake on Ga-68 PSMA imaging in locally advanced, recurrent or metastatic salivary gland cancers and other rare cancer.

    Through study completion, to June 2024.

Secondary Outcomes (1)

  • Correlation between in vitro PSMA expression and PSMA-ligand uptake on Ga-68 PSMA imaging in locally advanced, recurrent or metastatic salivary gland cancers and other rare cancers.

    Through study completion, to June 2024.

Study Arms (1)

68-Ga PSMA PET scan

68-Ga PSMA PET scan

Diagnostic Test: 68-Ga PSMA PET scan

Interventions

68-Ga PSMA PET scanDIAGNOSTIC_TEST

On the scheduled visit date for the study, * An intravenous cannula (plug) will be inserted in a vein in the participant's arm, through which the 68-Ga PSMA radiotracer for the scan will be injected. The infusion will take about 1-2 minutes. * PET imaging will be performed with a dedicated PET/CT scanner. 2.5-6.0 mCi (depending on weight of the patient) of PSMA radiotracer will be injected intravenously.

68-Ga PSMA PET scan

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients would have to have histologically confirmed diagnoses, are above 21 years of age, have no contraindication to 68Ga-PSMA PET/CT and able to give consent.

You may qualify if:

  • Locally advanced, metastatic or locally recurrent salivary gland cancers OR rare cancers (Examples of rare cancers: thyroid ca, cholangio ca, pancreatic ca, gall bladder ca, sarcoma)
  • Sample of biopsied tissue available for analysis
  • Histologically confirmed diagnoses
  • Above 21 years of age
  • Able to provide informed consent

You may not qualify if:

  • Diagnosis of haematological malignancies
  • Patients with more than one cancer diagnosis
  • Contraindication to 68Ga-PSMA PET/CT
  • E.g.: pregnant patients, breast feeding patients, renal impairment, liver impairment, allergy to components of the test
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow up schedule
  • Ongoing participation in any other clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Centre Singapore

Singapore, 169610, Singapore

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

  • Dr Wen-Long NEI, MD

    National Cancer Centre, Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2022

First Posted

October 17, 2022

Study Start

January 26, 2022

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

July 25, 2025

Record last verified: 2025-07

Locations

SG(1)