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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

Primary Purpose

Tuberculosis, Pulmonary

Status

Unknown status

Phase

Phase 1

Locations

Singapore

Study Type

Interventional

Intervention

FDG ligand

DOTANOC ligand

About this trial

This is an interventional diagnostic trial for Tuberculosis, Pulmonary

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

National University HospitalRecruiting
Tan Tock Seng HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FDG PET/MRI, DOTANOC PET/MRI

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02967666

First Posted

November 16, 2016

Last Updated

November 16, 2016

Sponsor

National University Hospital, Singapore

1. Study Identification

Unique Protocol Identification Number

NCT02967666

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Unknown status

Study Start Date

November 2016 (undefined)

Primary Completion Date

May 2017 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National University Hospital, Singapore

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tuberculosis, Pulmonary

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

FDG PET/MRI, DOTANOC PET/MRI

Arm Type

Experimental

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

FDG ligand

Other Intervention Name(s)

18F-Fludeoxyglucose

Intervention Type

Radiation

Intervention Name(s)

DOTANOC ligand

Other Intervention Name(s)

68Ga-DOTANOC

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Claire Naftalin

Phone

(65) 6601 5373

claire_naftalin@nuhs.edu.sg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicholas Paton

Organizational Affiliation

National University Hospital, Singapore

Official's Role

Principal Investigator

Facility Information:

Facility Name

National University Hospital

City

Singapore

Country

Singapore

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Claire Naftalin

Phone

(65) 6601 5373

claire_naftalin@nuhs.edu.sg

Facility Name

Tan Tock Seng Hospital

City

Singapore

Country

Singapore

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sonny YT Wang

Phone

(65) 6511 5131

12. IPD Sharing Statement

Learn more about this trial

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

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