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

Primary Purpose

Tuberculosis

Status
Unknown status
Phase
Phase 1
Locations
Singapore
Study Type
Interventional
Intervention
68Ga-DOTANOC PET/MRI
18F-FDG PET/MRI
Sponsored by
National University Hospital, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Tuberculosis

Eligibility Criteria

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

Inclusion Criteria:

  1. Age 21 years and above
  2. Willing to comply with the study visits and procedures
  3. Willing and able to provide written informed consent
  4. 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
  5. Not on TB treatment or have completed less than 28 days of TB treatment

Exclusion Criteria:

  1. Diabetes that is, in the judgment of the investigator, so poorly controlled that it would prevent adequate PET scanning
  2. Cardiac pacemaker, aneurysm clip or other metallic implant considered unsafe for MRI
  3. Known chronic kidney disease
  4. Occupation involving substantial exposure to radiation
  5. Malignancy requiring chemotherapy or radiation
  6. 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

68Ga-DOTANOC PET/MRI

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Comparison of uptake of 68Ga-DOTANOC with that of 18F-FDG in pulmonary TB.
Different uptake values between and within the pulmonary lesions will be measured and compared between the 2 tracers.
Establishment of optimal timing for a 68Ga-DOTANOC PET scan to evaluate TB lung pathology
The net tracer uptake rate for 68Ga-DOTANOC (Ki) will be derived from kinetic analysis in combination with dynamic imaging and the relationship between SUV and Ki.

Full Information

First Posted
July 17, 2016
Last Updated
April 12, 2017
Sponsor
National University Hospital, Singapore
Collaborators
Tan Tock Seng Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02845570
Brief Title
Evaluation of Somatostatin Receptor Imaging Using PET/MRI as a Novel Approach to Detecting Pathology in Pulmonary TB
Official Title
Evaluation of Somatostatin Receptor Imaging Using PET/MRI as a Novel Approach to Detecting Pathology in Pulmonary TB
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University Hospital, Singapore
Collaborators
Tan Tock Seng Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Granulomas, the hallmark of tuberculosis (TB) infection, have an increased density of somatostatin receptors. Somatostatin analog PET tracers, such as 68Ga-DOTANOC, may be able to identify these pulmonary granulomas. Although currently used for other medical indications, 68Ga-DOTANOC PET scanning has not previously been used to detect TB lesions. This is a pilot study which aims to assess the ability of 68Ga-DOTANOC PET/MRI to detect pulmonary lesions in individuals with active pulmonary tuberculosis. The 68Ga-DOTANOC PET scan and 'standard' 18F-fludeoxyglucose (FDG) PET scan will be compared to enable analysis of differences in uptake between these tracers in terms of number, size and distribution of lesions. Demonstrating the clinical utility of 68Ga-DOTANOC in active pulmonary TB is necessary prior to using this PET tracer to further explore other potential uses in TB such as identifying individuals with latent TB who are at risk of progressing to active TB, measuring therapeutic response to TB treatment and identifying extrapulmonary lesions.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
68Ga-DOTANOC PET/MRI
Arm Type
Experimental
Arm Description
Comparison between 68Ga-DOTANOC PET/MRI and 18F-FDG PET/MRI scans
Intervention Type
Other
Intervention Name(s)
68Ga-DOTANOC PET/MRI
Intervention Type
Other
Intervention Name(s)
18F-FDG PET/MRI
Primary Outcome Measure Information:
Title
Standard uptake value (SUV) of 68Ga-DOTANOC in pulmonary TB lesions using PET/MRI
Time Frame
Within 28 days of commencing TB treatment
Secondary Outcome Measure Information:
Title
Comparison of uptake of 68Ga-DOTANOC with that of 18F-FDG in pulmonary TB.
Description
Different uptake values between and within the pulmonary lesions will be measured and compared between the 2 tracers.
Time Frame
Within 28 days of commencing TB treatment
Title
Establishment of optimal timing for a 68Ga-DOTANOC PET scan to evaluate TB lung pathology
Description
The net tracer uptake rate for 68Ga-DOTANOC (Ki) will be derived from kinetic analysis in combination with dynamic imaging and the relationship between SUV and Ki.
Time Frame
Over 90 minutes from injection of tracer

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claire Naftalin
Phone
(65) 6601 5373
Email
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
Email
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 Somatostatin Receptor Imaging Using PET/MRI as a Novel Approach to Detecting Pathology in Pulmonary TB

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