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

NCT ID: NCT02967666

Last Updated: 2016-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Tuberculosis, Pulmonary

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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FDG PET/MRI, DOTANOC PET/MRI

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

Group Type EXPERIMENTAL

FDG ligand

Intervention Type RADIATION

DOTANOC ligand

Intervention Type RADIATION

Interventions

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FDG ligand

Intervention Type RADIATION

DOTANOC ligand

Intervention Type RADIATION

Other Intervention Names

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18F-Fludeoxyglucose 68Ga-DOTANOC

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National University Hospital, Singapore

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicholas Paton

Role: PRINCIPAL_INVESTIGATOR

National University Hospital, Singapore

Locations

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National University Hospital

Singapore, , Singapore

Site Status RECRUITING

Tan Tock Seng Hospital

Singapore, , Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Claire Naftalin

Role: CONTACT

Phone: (65) 6601 5373

Email: [email protected]

Facility Contacts

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Claire Naftalin

Role: primary

Sonny YT Wang

Role: primary

Other Identifiers

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DOTANOC_contacts

Identifier Type: -

Identifier Source: org_study_id