Evaluation of PET/MRI Using a Somatostatin Analog Tracer as a Novel Approach to Detecting Pathology in High Risk TB-exposed Contacts

November 16, 2016 updated by: National University Hospital, Singapore
PET/MRI (positron emission tomography/magnetic resonance imaging) with somatostatin analog tracers has the potential to provide an imaging technique targeting subclinical granulomatous disease in those with latent tuberculosis (TB), allowing identification of individuals who may be at risk of progression to active TB.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Granulomas, the hallmark of TB infection, have an increased density of somatostatin receptors. Somatostatin analog PET tracers, such as 68Ga-DOTANOC, bind to somatostatin receptors and are able to detect pulmonary TB lesions using PET/MRI. This study aims to better understand the pathology of the spectrum of latent TB using 68Ga-DOTANOC PET/MRI imaging, identifying individuals with subclinical pulmonary TB who may be at risk of progressing to active TB.

Currently, biomarkers to identify those who are at risk of developing active TB are limited. Non-invasive biomarkers for pulmonary lesions are sorely needed and imaging with 68Ga-DOTANOC PET/MRI provides an opportunity to detect subclinical pulmonary disease in those who have been in close contact with smear-positive pulmonary TB.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 1

Contacts and Locations

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

Study Locations

  • Singapore
      • Singapore, Singapore
      • Singapore, Singapore
        • Recruiting
        • Tan Tock Seng Hospital
        • Contact:
          • Sonny YT Wang
          • Phone Number: (65) 6511 5131

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:

  1. Age 21 years or over
  2. Close household contact of any patient with newly-diagnosed (within last 2 months) smear positive pulmonary TB (close contact defined as sleeping in the same house for at least one month with a TB patient prior to start of treatment).
  3. Interferon Gamma Release Assay (IGRA) positive
  4. Willing to comply with the study visits and procedures
  5. Willing and able to provide written informed consent

Exclusion Criteria:

  1. Previous treatment for TB disease
  2. Diabetes that is, in the judgment of the investigator, so poorly controlled that it would prevent adequate PET scanning
  3. Cardiac pacemaker, aneurysm clip or other metallic implant considered unsafe for MRI
  4. Occupation involving substantial exposure to radiation
  5. Malignancy requiring chemotherapy or radiation
  6. Known lung disease which may affect interpretation of the scan
  7. Known chronic kidney disease
  8. Symptoms, signs and/or previous investigations suggestive of active TB in the opinion of the investigator (cough for >1 month, cough productive of sputum or blood, shortness of breath, weight loss, night sweats, fever, abnormal examination, chest X-ray findings)
  9. Women who are currently pregnant or breastfeeding

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FDG PET/MRI, DOTANOC PET/MRI
FDG PET/MRI and DOTANOC PET/MRI will be performed.
Radiation: FDG ligand
Other Names:
  • 18F-Fludeoxyglucose
Radiation: DOTANOC ligand
Other Names:
  • 68Ga-DOTANOC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Standard uptake value (SUV) of 68Ga-DOTANOC in subclinical TB using PET/MRI
Time Frame: Within 2 months of exposure to smear-positive pulmonary TB
Within 2 months of exposure to smear-positive pulmonary TB

Collaborators and Investigators

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

Sponsor

National University Hospital, 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

November 1, 2016

Primary Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

November 16, 2016

First Submitted That Met QC Criteria

November 16, 2016

First Posted (Estimate)

November 18, 2016

Study Record Updates

Last Update Posted (Estimate)

November 18, 2016

Last Update Submitted That Met QC Criteria

November 16, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DOTANOC_contacts

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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