PSMA-PET Imaging of Salivary Gland Tumours and Other Rare Cancers

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.

Completed

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Key information

Conditions

Salivary Gland Tumor Adenocarcinoma Carcinoma Carcinoma, Adenoid Cystic Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Rare Malignant Neoplasm Salivary Gland Diseases Salivary Gland Neoplasms Stomatognathic Diseases

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Cancer Centre Singapore

Singapore, 169610

About this study

The potential participant will be screened and confirmed for eligibility by the appropriate study-team member. A signed IRB approved informed consent will be obtained prior to conducting any study-related procedures.

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.
A PET scan will be done around 60 minutes after the injection of the 68-Ga PSMA imaging agent.
During imaging, the participant will be asked to lie still and may be asked to hold his/her breath for a few seconds.
Imaging will be performed using a PET/CT, which will take 30 to 40 minutes to complete. Imaging of the body from vertex to mid thigh or feet will be obtained.
After the completion of the scan, the plug will be removed.

A Final Study Visit will take place on that one scheduled day. The participant will not need to visit the doctor's office during the course of the study outside of their usual scheduled doctor's follow up appointments.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Those who do not meet above inclusion criteria
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

Treatment and study plan

68-Ga PSMA PET scan

Diagnostic 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.

Primary outcomes

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.

Time frame: Through study completion, to June 2024.

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.

Secondary outcomes

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.

Time frame: Through study completion, to June 2024.

Correlation between the value of IHC PSMA expression and the PSMA PET SUVmax in locally advanced, recurrent or metastatic salivary gland cancers and other rare cancers.

Sponsors and collaborators

Lead sponsor

National Cancer Centre, Singapore

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Oct 17, 2022
Registry last updated: Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed