Salivary Gland TumorNCT05581979
PSMA-PET Imaging of Salivary Gland Tumours and Other Rare Cancers
An observational study of Salivary Gland Tumor and Rare Malignant Neoplasm, run by National Cancer Centre, Singapore at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Salivary Gland Tumor, Rare Malignant Neoplasm
- What is being tested?
- 68-Ga PSMA PET scan
- Type of treatment
- Injection or infusion
- How many people
- 4 participants
- Where
- 1 siteSingapore
- Study dates
- 26 Jan 2022to 31 May 2023
- Phase
- Observational
- 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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Salivary Gland Tumor, Rare Malignant Neoplasm
- Being tested
- 68-Ga PSMA PET scan
- Keywords
- 68-Ga PSMA PET Imaging, Salivary Gland, Radiolabeling, Gallium-68, PET scan, Prostate Specific Membrane Antigen, Adenocystic Carcinoma, Rare Tumours
- Medical subject headings
- Salivary Gland Neoplasms, Carcinoma, Adenoid Cystic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 68-Ga PSMA PET scan | 68-Ga PSMA PET scan Receives: Diagnostic Test: 68-Ga PSMA PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: Through study completion, to June 2024.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start26 Jan 2022
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Salivary Gland TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Wen-Long NEI, MD, Principal investigator, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05581979
- Sponsor's protocol ID
- PSMA 01
- Status last verified
- Jul 2025
- First submitted
- 28 Sep 2022
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PSMA-PET Imaging of Salivary Gland Tumours and Other Rare Cancers
- ClinicalTrials.gov ID
- NCT05581979
- Acronym / sponsor ID
- PSMA 01
- Conditions
- Salivary Gland Tumor, Rare Malignant Neoplasm
- Keywords
- 68-Ga PSMA PET Imaging, Salivary Gland, Radiolabeling, Gallium-68, PET scan, Prostate Specific Membrane Antigen, Adenocystic Carcinoma, Rare Tumours
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 17 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68-Ga PSMA PET scan | – | Diagnostic Test: 68-Ga PSMA PET scan68-Ga PSMA PET scan |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow up schedule
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68-Ga PSMA PET scanOn 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. | Diagnostic test | 68-Ga PSMA PET scan |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Wen-Long NEI, MD principal investigator
National Cancer Centre, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Salivary Gland Tumor and Rare Malignant Neoplasm, run by National Cancer Centre, Singapore at 1 site in Singapore.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 25 Jul 2025. 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 Singapore. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2025.