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

NCT02967666 | Unknown Phase 1

• 1 other identifier: DOTANOC_contacts
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Tuberculosis, Pulmonary

Outcome Measures

Primary Outcomes (1)

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

  Within 2 months of exposure to smear-positive pulmonary TB

Study Arms (1)

FDG PET/MRI, DOTANOC PET/MRI

EXPERIMENTAL

FDG PET/MRI and DOTANOC PET/MRI will be performed.

Radiation: FDG ligand; Radiation: DOTANOC ligand

Interventions

FDG ligand RADIATION

Also known as: 18F-Fludeoxyglucose

FDG PET/MRI, DOTANOC PET/MRI

DOTANOC ligand RADIATION

Also known as: 68Ga-DOTANOC

FDG PET/MRI, 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 or over
• 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).
• Interferon Gamma Release Assay (IGRA) positive
• Willing to comply with the study visits and procedures
• Willing and able to provide written informed consent

You may not qualify if:

• Previous treatment for TB disease
• 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
• Occupation involving substantial exposure to radiation
• Malignancy requiring chemotherapy or radiation
• Known lung disease which may affect interpretation of the scan
• Known chronic kidney disease
• 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)
• Women who are currently pregnant or breastfeeding

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (2)

National University Hospital

Singapore, Singapore

RECRUITING

Tan Tock Seng Hospital

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Interventions

68Ga-DOTANOC

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

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: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: November 18, 2016
• Study Start: November 1, 2016
• Primary Completion: May 1, 2017
• Last Updated: November 18, 2016

Record last verified: 2016-11

Locations

SG (2)