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
About this trial
This is an interventional other trial for Tuberculosis
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
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
NCT ID
NCT02845570
First Posted
July 17, 2016
Last Updated
April 12, 2017
Sponsor
National University Hospital, Singapore
Collaborators
Tan Tock Seng Hospital
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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