NCT03535545

Preliminary Evaluation of [68Ga]CBP8 in Healthy Individuals, Lung Cancer, and Idiopathic Pulmonary Fibrosis Patients

Preliminary Evaluation of [68Ga]CBP8 in Healthy Individuals, Lung Cancer Patients Undergoing Radiation Therapy Prior to the Resection of Locally Advanced Tumors, and Idiopathic Pulmonary Fibrosis Patients

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to investigate the safety of \[68Ga\]CBP8 and its efficacy to detect collagen deposition in pulmonary fibrosis.

Detailed description

The investigators have developed \[68Ga\]CBP8, a gallium-68 labeled collagen binding PET imaging probe, which selectively binds collagen type I. Collagen deposition is a pivotal event in several human conditions including pulmonary fibrosis. The investigator's studies in mice showed that \[68Ga\]CBP8 binds collagen with high affinity and has excellent pharmacological and pharmacokinetic profiles with high target uptake and low retention in background tissues and organs. \[68Ga\]CBP8 was shown in a mouse model to be effective for detecting lung fibrosis. \[68Ga\]CBP8 showed high specificity for pulmonary fibrosis and high target:background ratios in diseased animals. In addition, \[68Ga\]CBP8 could be used to monitor response to treatment. Ex vivo analysis of lung tissue from patients with IPF supported the animal findings. The investigators thus aim to perform the first in human studies of \[68Ga\]CBP8: 1. To evaluate the safety of \[68Ga\]CBP8 and its whole body distribution, metabolism, pharmacokinetics, and radiation burden in healthy volunteers. 2. To establish the accuracy of \[68Ga\]CBP8-PET to detect radiation-induced fibrosis in lung cancer patients and correlate collagen-targeted \[68Ga\]CBP8-PET imaging with HRCT and histology in lung cancer patients. 3. To determine whether collagen deposition as assessed by \[68Ga\]CBP8-PET molecular imaging can predict disease progression in IPF patients and patients with other types of ILD with a fibrotic component.

Conditions

• Pulmonary Fibrosis
• Lung Cancer

Interventions

Type	Name	Description
DRUG	[68Ga]CBP8	Up to 15 mCi of \[68Ga\]CBP8 will be administered to each subject.
DIAGNOSTIC_TEST	PET Imaging	All subjects will undergo PET imaging after administration of \[68Ga\]CBP8.

Timeline

• Start date: 2018-08-01
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2018-05-24
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study