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Somatostatin Receptor Imaging in NPC, EBV Related Cancers

Primary Purpose

Nasopharyngeal Cancer, Epstein-Barr Virus Related Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
FDG-PET
Galium-68 DOTATATE
Sponsored by
National Cancer Centre, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Nasopharyngeal Cancer focused on measuring Somatostatin, EBV, NPC, Rare Cancer

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Cancer Centre SingaporeRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

PET imaging

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Number of somatostatin receptors in patient biopsy samples
Amount of somatostatin circulating tumour cells in patient blood samples

Full Information

First Posted
December 9, 2021
Last Updated
October 13, 2022
Sponsor
National Cancer Centre, Singapore
Collaborators
National Cancer Centre Research Fund
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1. Study Identification

Unique Protocol Identification Number
NCT05581550
Brief Title
Somatostatin Receptor Imaging in NPC, EBV Related Cancers
Official Title
Somatostatin Receptor Imaging in Nasopharyngeal Cancer, Epstein-Barr Virus (EBV) Related Cancers and Other Rare Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Centre, Singapore
Collaborators
National Cancer Centre Research Fund

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Cancer, Epstein-Barr Virus Related Carcinoma
Keywords
Somatostatin, EBV, NPC, Rare Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PET imaging
Arm Type
Other
Intervention Type
Radiation
Intervention Name(s)
FDG-PET
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Galium-68 DOTATATE
Intervention Description
200MBq +/- 10% Galium-68 DOTATATE will be injected intravenously. Scanning will be performed approximately 60 minutes after the injection.
Primary Outcome Measure Information:
Title
Amount of tracer uptake in the tumour lesions of NPC patients
Description
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.
Time Frame
From time of tracer injection to time the scan is performed
Secondary Outcome Measure Information:
Title
Amount of tracer uptake in the tumour lesions of patients with EBV related cancers
Description
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.
Time Frame
From time of tracer injection to time the scan is performed
Title
Number of somatostatin receptors in patient biopsy samples
Time Frame
Upon signing the informed consent form
Title
Amount of somatostatin circulating tumour cells in patient blood samples
Time Frame
At the time of scan

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wen Long Nei, MD
Phone
+65 6436 8000
Email
nei.wen.long@singhealth.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen Long Nei, MD
Organizational Affiliation
National Cancer Centre, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Centre Singapore
City
Singapore
Country
Singapore
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Somatostatin Receptor Imaging in NPC, EBV Related Cancers

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