drugset / Trial / NCT06265532
Collagen-targeted Positron Emission Tomography (PET) Imaging for Assessment of EGCG Effect
Phase 1
Completed
12 enrolled
Hal Chapman
Cornell University · collabMassachusetts General Hospital · collabNational Heart, Lung, and Blood Institute (NHLBI) · collabUniversity of Michigan · collab
RandomizedSequentialQuadruple-blindTreatment
Summary
The primary purpose of this substudy is to determine if collagen-targeted PET using the type 1 collagen-targeted PET probe, Gallium-68 (68Ga)-labeled collagen binding probe 8 (CBP8) can inform as to drug effect of EGCG and assist in dose selection.
Timeline
- Start
- 2024-02-07
- Primary completion
- 2026-01-08
- Completion
- 2026-01-08
Publications
- Background Montesi SB, Izquierdo-Garcia D, Desogere P, Abston E, Liang LL, Digumarthy S, Seethamraju R, Lanuti M, Caravan P, Catana C. Type I Collagen-targeted Positron Emission Tomography Imaging in Idiopathic Pulmonary Fibrosis: First-in-Human Studies. Am J Respir Crit Care Med. 2019 Jul 15;200(2):258-261. doi: 10.1164/rccm.201903-0503LE. No abstract available.
- Results Izquierdo-Garcia D, Desogere P, Fur ML, Shuvaev S, Zhou IY, Ramsay I, Lanuti M, Catalano OA, Catana C, Caravan P, Montesi SB. Biodistribution, Dosimetry, and Pharmacokinetics of 68Ga-CBP8: A Type I Collagen-Targeted PET Probe. J Nucl Med. 2023 May;64(5):775-781. doi: 10.2967/jnumed.122.264530. Epub 2022 Dec 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | epigallocatechin-3-gallate | Other / unclassified | 300 mg | Oral |
| Comparator | epigallocatechin-3-gallate | Other / unclassified | 600 mg | Oral |