Evaluation of Somatostatin Receptor Imaging Using PET/MRI... | NCT02845570

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

NCT02845570

Sponsor

National University Hospital, Singapore

Status

Unknown status

Last Update Posted

Apr 13, 2017Actual

Enrollment

8Estimated

Phase

Phase 1

Conditions

Tuberculosis

Interventions

68Ga-DOTANOC PET/MRI
18F-FDG PET/MRI

Countries

Singapore

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016

Primary Completion Date

Aug 2017Estimated

Completion Date

Not provided

First Submitted Date

Jul 17, 2016

First Submission Date that Met QC Criteria

Jul 22, 2016

First Posted Date

Jul 27, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2017

Last Update Posted Date

Apr 13, 2017Actual

Name	Class
Tan Tock Seng Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
68Ga-DOTANOC PET/MRI	Experimental	Comparison between 68Ga-DOTANOC PET/MRI and 18F-FDG PET/MRI scans	Other: 68Ga-DOTANOC PET/MRI Other: 18F-FDG PET/MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
68Ga-DOTANOC PET/MRI	Other		68Ga-DOTANOC PET/MRI
18F-FDG PET/MRI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Standard uptake value (SUV) of 68Ga-DOTANOC in pulmonary TB lesions using PET/MRI		Within 28 days of commencing TB treatment

Secondary Outcomes

Measure	Description	Time Frame
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.	Within 28 days of commencing TB treatment
Establishment of optimal timing for a 68Ga-DOTANOC PET scan to evaluate TB lung pathology

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Claire Naftalin	Contact	(65) 6601 5373		claire_naftalin@nuhs.edu.sg

Overall Officials

Name	Affiliation	Role
Nicholas Paton	National University Hospital, Singapore	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National University Hospital	Recruiting	Singapore			Singapore

Condition Browse Module

MeSH Terms

ID	Term
D014376	Tuberculosis

Ancestor Terms

ID	Term
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections

Browse Leaves

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Browse Branches

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