Evaluation of Somatostatin Receptor Imaging Using PET/MRI as a Novel Approach to Detecting Pathology in Pulmonary TB
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
-
Singapore, Singapore
- Rekruttering
- National University Hospital
-
Ta kontakt med:
- Claire Naftalin
- Telefonnummer: (65) 6601 5373
- E-post: claire_naftalin@nuhs.edu.sg
-
Singapore, Singapore
- Rekruttering
- Tan Tock Seng Hospital
-
Ta kontakt med:
- Sonny YT Wang
- Telefonnummer: (65) 6511 5131
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 68Ga-DOTANOC PET/MRI
Comparison between 68Ga-DOTANOC PET/MRI and 18F-FDG PET/MRI scans
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Standard uptake value (SUV) of 68Ga-DOTANOC in pulmonary TB lesions using PET/MRI
Tidsramme: Within 28 days of commencing TB treatment
|
Within 28 days of commencing TB treatment
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Comparison of uptake of 68Ga-DOTANOC with that of 18F-FDG in pulmonary TB.
Tidsramme: Within 28 days of commencing TB treatment
|
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
Tidsramme: Over 90 minutes from injection of tracer
|
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
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Infeksjoner
- Luftveisinfeksjoner
- Sykdommer i luftveiene
- Lungesykdommer
- Bakterielle infeksjoner
- Bakterielle infeksjoner og mykoser
- Gram-positive bakterielle infeksjoner
- Actinomycetales infeksjoner
- Mycobacterium infeksjoner
- Tuberkulose
- Tuberkulose, lunge
- Molekylære mekanismer for farmakologisk virkning
- Radiofarmasøytiske midler
- Fluorodeoksyglukose F18
Andre studie-ID-numre
- DOTANOC TB
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .