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FP-R01-MG-F2 · 1 trial · 3 indications
The SUVmax in a lung or liver with known IPF, COVID19 pneumonia, or PSC respectively will be compared to the SUVmax in a known healthy lung/liver. It is expected that the SUV max, which is a measurement of the maximum value of radiopharmaceutical uptake within the region of interest (ROI) in IPF, COVID19 pneumonia, and PSC will be higher than the SUV max in the healthy lung/liver.
| Arm | Type | Description |
|---|---|---|
| [18F]FP-R01-MG-F2 PET/CT in IPF Patients, Recovered COVID19 Patients, and Healthy Volunteers | EXPERIMENTAL | Arm1: 7mCi (range 6-9 mCi) \[18F\]FP-R01-MG-F2 will be administered to the study participant. A 60-minute dynamic PET/CT scan to the center of the lungs in the FOV is followed by two vertex-to-thigh PET/CT scans. NOTE: If the patient cannot tolerate lying down for an extended period of time at the time of imaging, the patient may be switched to scanning protocol Option B, which does not include an initial 60-minute dynamic PET/CT scan. IPF Patients will have a repeat \[18F\]FP-R01-MG-F2 PET/CT scan performed within 3-8 weeks post initial scan (within 12-24 months post initial scan for previously scanned IPF patients if they are willing to be re-consented). |
| [18F]FP-R01-MG-F2 PET/CT in PSC Patients | EXPERIMENTAL | Arm 2: 7mCi (range 6-9 mCi) \[18F\]FP-R01-MG-F2 will be administered to the study participant. A 60-minute dynamic PET/CT scan to the center of the liver in the FOV is followed by two vertex-to-thigh PET/CT scans. Patients will have the option for a repeat \[18F\]FP-R01-MG-F2 PET/CT scan performed within 3-8 weeks post initial scan. |
| [18F]FP-R01-MG-F2 PET/CT in actively infected COVID19 Patients | EXPERIMENTAL | Arm 3: 7mCi (range 6-9 mCi) \[18F\]FP-R01-MG-F2 will be administered to the study participant. One vertex-to-thigh PET/CT scans to the center of the lung in the FOV will follow approximately 60 min post-injection. |
| Name | Type | Description |
|---|---|---|
| [18F]FP-R01-MG-F2 | DRUG | 7mCi (range 6-9mCi) \[18F\]FP-R01-MG-F2 will be administered |
1.0 Eligibility Criteria for IPF Patients 1.1 Inclusion Criteria The following inclusion criteria will be monitored: * Patient is \>/= 18 years old * Patient is capable of making an informed decision regarding his/her treatment * Patient diagnosed with IPF by a pulmonologist according to ATS guid...
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FP-R01-MG-F2 is an investigational small molecule imaging agent developed by Pliant Therapeutics, Inc. (ticker PLRX). It is designed for use in positron emission tomography (PET) imaging to detect integrin alpha-v beta-6 in patients with idiopathic pulmonary fibrosis and other conditions. It is not a therapeutic treatment.
FP-R01-MG-F2 is used as a PET/CT imaging agent to detect integrin alpha-v beta-6 in patients with idiopathic pulmonary fibrosis. It is intended to help visualize and quantify target expression in the lungs. The compound is investigational and has been studied in a completed early-phase clinical trial.
FP-R01-MG-F2 is developed by Pliant Therapeutics, Inc., which trades on the Nasdaq under the ticker symbol PLRX. The company is the sponsor of the clinical study evaluating this imaging agent.
FP-R01-MG-F2 is in Phase 1 development. It has been evaluated in one completed early-phase clinical trial and is not approved by the FDA. It remains an investigational imaging agent.
FP-R01-MG-F2 has been studied in one completed clinical trial, NCT03183570, titled Detection of Integrin avb6 in IPF, PSC, and COVID19 Using PET/CT. The trial enrolled 21 participants across sites in the United States and included adults aged 18 years and older.