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

Sponsor

National Cancer Centre, Singapore (Other)

Overall Status

Recruiting

CT.gov ID

NCT05581979

Collaborator

(none)

Enrollment

Location

28.2

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Salivary Gland Tumor Rare Malignant Neoplasm	Diagnostic Test: 68-Ga PSMA PET scan

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

24 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 26, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
68-Ga PSMA PET scan 68-Ga PSMA PET scan	Diagnostic Test: 68-Ga PSMA PET scan 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.

Arm

Intervention/Treatment

68-Ga PSMA PET scan

Diagnostic Test: 68-Ga PSMA PET scan

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.

Outcome Measures

Primary Outcome Measures

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. [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 Outcome Measures

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.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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