Somatostatin Receptor Imaging in NPC, EBV Related Cancers

October 13, 2022 updated by: National Cancer Centre, Singapore

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Singapore
      • Singapore, Singapore
        • Recruiting
        • National Cancer Centre Singapore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: PET imaging
Radiation: FDG-PET
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.
Radiation: Galium-68 DOTATATE
200MBq +/- 10% Galium-68 DOTATATE will be injected intravenously. Scanning will be performed approximately 60 minutes after the injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From time of tracer injection to time the scan is performed

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Number of somatostatin receptors in patient biopsy samples
Time Frame: Upon signing the informed consent form
Upon signing the informed consent form
Amount of somatostatin circulating tumour cells in patient blood samples
Time Frame: At the time of scan
At the time of scan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Centre, Singapore

Collaborators

National Cancer Centre Research Fund

Investigators

  • Principal Investigator: Wen Long Nei, MD, National Cancer Centre, Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 29, 2020

Primary Completion (ANTICIPATED)

December 31, 2022

Study Completion (ANTICIPATED)

December 31, 2022

Study Registration Dates

First Submitted

December 9, 2021

First Submitted That Met QC Criteria

October 13, 2022

First Posted (ACTUAL)

October 14, 2022

Study Record Updates

Last Update Posted (ACTUAL)

October 14, 2022

Last Update Submitted That Met QC Criteria

October 13, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPC EBV SSTR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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