Somatostatin Receptor Imaging in NPC, EBV Related Cancers

Nasopharyngeal Cancer Clinical Trial

Official title:

Somatostatin Receptor Imaging in Nasopharyngeal Cancer, Epstein-Barr Virus (EBV) Related Cancers and Other Rare Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05581550
• Other study ID #: NPC EBV SSTR
• Status: Recruiting
• Phase: N/A
• Start date: June 29, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2022
• Source: National Cancer Centre, Singapore
• Contact: Wen Long Nei, MD
• Phone: +65 6436 8000
• Email: nei.wen.long[@]singhealth.com.sg
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epstein-Barr Virus Infections
• Nasopharyngeal Cancer
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Singapore	National Cancer Centre Singapore	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National Cancer Centre, Singapore	National Cancer Centre Research Fund

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	From time of tracer injection to time the scan is performed
Secondary	Number of somatostatin receptors in patient biopsy samples		Upon signing the informed consent form
Secondary	Amount of somatostatin circulating tumour cells in patient blood samples		At the time of scan