Nasopharyngeal CancerNCT05581550
Somatostatin Receptor Imaging in NPC, EBV Related Cancers
A study testing FDG-PET and Galium-68 DOTATATE in people with Nasopharyngeal Cancer and Epstein-Barr Virus Related Carcinoma, run by National Cancer Centre, Singapore at 1 site in Singapore.
Trial summary
The study aims to describe the avidity of somatostatin receptors in locally advanced, metastatic and locally recurrent nasopharyngeal cancer (NPC) and to determine the proportion of NPC patients with high somatostatin receptor density that may benefit from future somatostatin targeted therapeutic trial plans. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Nasopharyngeal Cancer, Epstein-Barr Virus Related Carcinoma
- What is being tested?
- FDG-PET and Galium-68 DOTATATE
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSingapore
- Study dates
- 29 Jun 2020to 17 Jul 2025
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Locally advanced, metastatic or locally recurrent NPC that are going for FDG PET as part of their investigations
- Patients that have gone for Ga-68 DOTATATE imaging before are eligible for repeat imaging
- Histologically confirmed NPC
- Above 21 years of age
Who cannot join
- Patients below 21 years of age
- Pregnant and breast feeding ladies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Somatostatin Receptor Imaging in Nasopharyngeal Cancer, Epstein-Barr Virus (EBV) Related Cancers and Other Rare Tumors
The study aims to describe the avidity of somatostatin receptors in locally advanced, metastatic and locally recurrent nasopharyngeal cancer (NPC) and to determine the proportion of NPC patients with high somatostatin receptor density that may benefit from future somatostatin targeted therapeutic trial plans. The investigators also aim to determine the presence of somatostatin receptors in other EBV related cancers.
- Being tested
- FDG-PET, Galium-68 DOTATATE
- Keywords
- Somatostatin, EBV, NPC, Rare Cancer
- Medical subject headings
- Nasopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG-PETRadiation
Patients will be fasted for 6 hours prior to intravenous injection of 370MBq +/- 10% (18)F-fluorodeoxyglucose. Scanning will be performed at an interval of at least 60 minutes following the injection.
Galium-68 DOTATATERadiation
200MBq +/- 10% Galium-68 DOTATATE will be injected intravenously. Scanning will be performed approximately 60 minutes after the injection.
| Study group | Role | What they receive |
|---|---|---|
| PET imaging | Other | Not described Receives: Radiation: FDG-PET; Radiation: Galium-68 DOTATATE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of tracer uptake in the tumour lesions of NPC patients
The maximum standardized uptake values (SUVmax) will be measured. If the average SUVmax of all the lesions is more than 10, the patient will be considered to have an overall high somatostatin receptor density.
Measured: From time of tracer injection to time the scan is performed
Secondary outcomes (3)
Amount of tracer uptake in the tumour lesions of patients with EBV related cancers
The maximum standardized uptake values (SUVmax) will be measured. If the average SUVmax of all the lesions is more than 10, the patient will be considered to have an overall high somatostatin receptor density.
Measured: From time of tracer injection to time the scan is performed
Number of somatostatin receptors in patient biopsy samples
Measured: Upon signing the informed consent form
Amount of somatostatin circulating tumour cells in patient blood samples
Measured: At the time of scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start29 Jun 2020
- Primary completion17 Jul 2025
- Study completion17 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Centre Research Fund
- Responsible party
- Sponsor
- Investigators
- Wen Long Nei, MD, Principal investigator, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05581550
- Sponsor's protocol ID
- NPC EBV SSTR
- Status last verified
- Jul 2025
- First submitted
- 9 Dec 2021
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Somatostatin Receptor Imaging in Nasopharyngeal Cancer, Epstein-Barr Virus (EBV) Related Cancers and Other Rare Tumors
- ClinicalTrials.gov ID
- NCT05581550
- Acronym / sponsor ID
- NPC EBV SSTR
- Keywords
- Somatostatin, EBV, NPC, Rare Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Collaborators
- National Cancer Centre Research Fund
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 17 Jul 2025 (actual)
- Study completion
- 17 Jul 2025 (actual)
- First posted
- 14 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 study aims to describe the avidity of somatostatin receptors in locally advanced, metastatic and locally recurrent nasopharyngeal cancer (NPC) and to determine the proportion of NPC patients with high somatostatin receptor density that may benefit from future somatostatin targeted therapeutic trial plans. The investigators also aim to determine the presence of somatostatin receptors in other EBV related cancers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET imaging | Other | Radiation: FDG-PET, Radiation: Galium-68 DOTATATE |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Locally advanced, metastatic or locally recurrent NPC that are going for FDG PET as part of their investigations
- Patients that have gone for Ga-68 DOTATATE imaging before are eligible for repeat imaging
- Histologically confirmed NPC
- Above 21 years of age
Key exclusion criteria (2 listed)
- Patients below 21 years of age
- Pregnant and breast feeding ladies
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 |
|---|---|---|
| FDG-PETPatients will be fasted for 6 hours prior to intravenous injection of 370MBq +/- 10% (18)F-fluorodeoxyglucose. Scanning will be performed at an interval of at least 60 minutes following the injection. | Radiation | PET imaging |
| Galium-68 DOTATATE200MBq +/- 10% Galium-68 DOTATATE will be injected intravenously. Scanning will be performed approximately 60 minutes after the injection. | Radiation | PET imaging |
Primary outcome
Amount of tracer uptake in the tumour lesions of NPC patients
Time frame: From time of tracer injection to time the scan is performed
The maximum standardized uptake values (SUVmax) will be measured. If the average SUVmax of all the lesions is more than 10, the patient will be considered to have an overall high somatostatin receptor density.
3 secondary outcomes
Amount of tracer uptake in the tumour lesions of patients with EBV related cancers
Time frame: From time of tracer injection to time the scan is performed
Number of somatostatin receptors in patient biopsy samples
Time frame: Upon signing the informed consent form
Amount of somatostatin circulating tumour cells in patient blood samples
Time frame: At the time of scan
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 20 Jul 2025.
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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.
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?
A study testing FDG-PET and Galium-68 DOTATATE in people with Nasopharyngeal Cancer and Epstein-Barr Virus Related Carcinoma, 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 4 inclusion and 2 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 20 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?
Amount of tracer uptake in the tumour lesions of NPC patients (time frame: From time of tracer injection to time the scan is performed). 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 20 Jul 2025.