Evaluation of Somatostatin Receptor Imaging Using PET/MRI as a Novel Approach to Detecting Pathology in Pulmonary TB
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 1
Kontakter och platser
Studieorter
-
-
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Singapore, Singapore
- Rekrytering
- National University Hospital
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Kontakt:
- Claire Naftalin
- Telefonnummer: (65) 6601 5373
- E-post: claire_naftalin@nuhs.edu.sg
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Singapore, Singapore
- Rekrytering
- Tan Tock Seng Hospital
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Kontakt:
- Sonny YT Wang
- Telefonnummer: (65) 6511 5131
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 68Ga-DOTANOC PET/MRI
Comparison between 68Ga-DOTANOC PET/MRI and 18F-FDG PET/MRI scans
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Standard uptake value (SUV) of 68Ga-DOTANOC in pulmonary TB lesions using PET/MRI
Tidsram: Within 28 days of commencing TB treatment
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Within 28 days of commencing TB treatment
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Comparison of uptake of 68Ga-DOTANOC with that of 18F-FDG in pulmonary TB.
Tidsram: Within 28 days of commencing TB treatment
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Different uptake values between and within the pulmonary lesions will be measured and compared between the 2 tracers.
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Within 28 days of commencing TB treatment
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Establishment of optimal timing for a 68Ga-DOTANOC PET scan to evaluate TB lung pathology
Tidsram: Over 90 minutes from injection of tracer
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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.
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Over 90 minutes from injection of tracer
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Samarbetspartners och utredare
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Infektioner
- Luftvägsinfektioner
- Luftvägssjukdomar
- Lungsjukdomar
- Bakteriella infektioner
- Bakteriella infektioner och mykoser
- Gram-positiva bakteriella infektioner
- Actinomycetales infektioner
- Mycobacterium infektioner
- Tuberkulos
- Tuberkulos, lung
- Molekylära mekanismer för farmakologisk verkan
- Radiofarmaka
- Fluorodeoxiglukos F18
Andra studie-ID-nummer
- DOTANOC TB
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