Evaluation of Somatostatin Receptor Imaging Using PET/MRI as a Novel Approach to Detecting Pathology in Pulmonary TB

NCT02845570 | Unknown Phase 1

• 1 other identifier: DOTANOC TB
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief Summary

Imaging using 68Ga-DOTANOC PET (positron emission tomography) has the potential to detect granulomas in pulmonary tuberculosis, leading to previously unexplored indications for this PET tracer, including identification of subclinical disease in latently infected individuals. This study aims to assess the ability of 68Ga-DOTANOC PET/MRI to detect pulmonary lesions in individuals with active pulmonary tuberculosis.

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Standard uptake value (SUV) of 68Ga-DOTANOC in pulmonary TB lesions using PET/MRI

  Within 28 days of commencing TB treatment

Secondary Outcomes (2)

• Comparison of uptake of 68Ga-DOTANOC with that of 18F-FDG in pulmonary TB.

  Within 28 days of commencing TB treatment

• Establishment of optimal timing for a 68Ga-DOTANOC PET scan to evaluate TB lung pathology

  Over 90 minutes from injection of tracer

Study Arms (1)

68Ga-DOTANOC PET/MRI

EXPERIMENTAL

Comparison between 68Ga-DOTANOC PET/MRI and 18F-FDG PET/MRI scans

Other: 68Ga-DOTANOC PET/MRI; Other: 18F-FDG PET/MRI

Interventions

68Ga-DOTANOC PET/MRI OTHER

68Ga-DOTANOC PET/MRI

18F-FDG PET/MRI OTHER

68Ga-DOTANOC PET/MRI

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21 years and above
• Willing to comply with the study visits and procedures
• Willing and able to provide written informed consent
• Clinical diagnosis of pulmonary TB with characteristic symptoms and compatible X-ray findings plus microbiological confirmation with one or more of (i) Acid fast bacilli (AFB) smear-positive or (ii) molecular test positive or (iii) TB culture positive
• Not on TB treatment or have completed less than 28 days of TB treatment

You may not qualify if:

• Diabetes that is, in the judgment of the investigator, so poorly controlled that it would prevent adequate PET scanning
• Cardiac pacemaker, aneurysm clip or other metallic implant considered unsafe for MRI
• Known chronic kidney disease
• Occupation involving substantial exposure to radiation
• Malignancy requiring chemotherapy or radiation
• Women who are currently pregnant or breastfeeding

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• Tan Tock Seng Hospital: collaborator

Study Sites (2)

National University Hospital

Singapore, Singapore

RECRUITING

Tan Tock Seng Hospital

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Nicholas Paton

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claire Naftalin

CONTACT

(65) 6601 5373; claire_naftalin@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2016
• First Posted: July 27, 2016
• Study Start: July 1, 2016
• Primary Completion: August 1, 2017
• Last Updated: April 13, 2017

Record last verified: 2016-07

Locations

SG (2)