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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21AI192087-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| SOFIE | INDUSTRY |
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The investigators will assess the hypothesis is that 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) Positron emission tomography (PET) could be used as a noninvasive biomarker to assess post-tuberculosis (post-TB) lung disease and fibrosis in TB patients.
Microbiologically confirmed patients with active tuberculosis will be invited to participate in the study. A whole-body PET scan will be performed after 18F-FAPI-74 intravenous injection and correlation will be made with sites of TB lesions noted on CT. It is anticipated that 18F-FAPI-74 PET will be able to detect fibrosis (with high sensitivity) in the TB lesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-FAPI-74 PET/CT | A single intravenous dose of 18F-FAPI-74 followed by PET/CT scan pre- and post-TB treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-FAPI-74 | Combination Product | 7 millicurie (mCi) of 18F-FAPI-74 in adult tuberculosis patient followed by a PET/CT scan, performed during the first 6 weeks of treatment and/or a second dose of 7 millicurie (mCi) of 18F-FAPI-74 in adult tuberculosis patient followed by a PET/CT scan within 6 weeks after tuberculosis treatment completion. |
| Measure | Description | Time Frame |
|---|---|---|
| Uptake of 18F-FAPI-74 derived by the standardized uptake value ratio (SUVr) | Characterization of lesional fibrosis using 18F-FAPI-74 PET/CT in tuberculosis patients. Whole-body PET/CT scans will be obtained after intravenous injection of 18F-FAPI-74. Uptake will be measured at sites of TB lesions and unaffected areas. | Up to 1 hour |
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Inclusion criteria: Patients may be enrolled into this protocol only if all the following inclusion criteria are met:
Exclusion criteria: Patients will be excluded from enrollment if any of the following apply:
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Males and female members of all races and ethnic groups are eligible for this trial and encouraged to participate.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sanjay K Jain, MD | Contact | 513-636-7056 | sanjay.jain@cchmc.org |
| Name | Affiliation | Role |
|---|---|---|
| Sanjay Jain, MD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Recruiting | Cincinnati | Ohio | 45229 | United States |
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| ID | Term |
|---|---|
| D014397 | Tuberculosis, Pulmonary |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
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| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |