NCT05581550

Brief 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. The investigators also aim to determine the presence of somatostatin receptors in other EBV related cancers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2020

Longer than P75 for not_applicable

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

June 29, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2021

Completed
10 months until next milestone

First Posted

Study publicly available on registry

October 14, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2025

Completed
Last Updated

July 20, 2025

Status Verified

July 1, 2025

Enrollment Period

5.1 years

First QC Date

December 9, 2021

Last Update Submit

July 17, 2025

Conditions

Keywords

SomatostatinEBVNPCRare Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    From time of tracer injection to time the scan is performed

  • Number of somatostatin receptors in patient biopsy samples

    Upon signing the informed consent form

  • Amount of somatostatin circulating tumour cells in patient blood samples

    At the time of scan

Study Arms (1)

PET imaging

OTHER
Radiation: FDG-PETRadiation: Galium-68 DOTATATE

Interventions

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.

PET imaging

200MBq +/- 10% Galium-68 DOTATATE will be injected intravenously. Scanning will be performed approximately 60 minutes after the injection.

PET imaging

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients below 21 years of age
  • Pregnant and breast feeding ladies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Centre Singapore

Singapore, Singapore

Location

MeSH Terms

Conditions

Nasopharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Wen Long Nei, MD

    National Cancer Centre, Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2021

First Posted

October 14, 2022

Study Start

June 29, 2020

Primary Completion

July 17, 2025

Study Completion

July 17, 2025

Last Updated

July 20, 2025

Record last verified: 2025-07

Locations