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

Tuberculosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02845570
• Other study ID #: DOTANOC TB
• Status: Recruiting
• Phase: Phase 1
• First received: July 17, 2016
• Last updated: April 12, 2017
• Start date: July 2016

Study information

• Verified date: July 2016
• Source: National University Hospital, Singapore
• Contact: Claire Naftalin
• Phone: (65) 6601 5373
• Email: claire_naftalin[@]nuhs.edu.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tuberculosis
• Tuberculosis, Pulmonary

Intervention

Other:
• 68Ga-DOTANOC PET/MRI

• 18F-FDG PET/MRI

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore
Singapore	Tan Tock Seng Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University Hospital, Singapore	Tan Tock Seng Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standard uptake value (SUV) of 68Ga-DOTANOC in pulmonary TB lesions using PET/MRI		Within 28 days of commencing TB treatment
Secondary	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
Secondary	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.	Over 90 minutes from injection of tracer