NCT04485286

Evaluation of PET Probe [68Ga]CBP8 in the Detection of Radiation Induced Tissue Injury

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to investigate the efficacy of \[68Ga\]CBP8 to detect collagen deposition in radiation induced tissue injury.

Detailed description

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 radiation induced lung injury and in response to radiation therapy in pancreatic cancer. The investigator's studies in murine models of lung injury including radiation induced lung injury 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 idiopathic pulmonary fibrosis (IPF) supported the animal findings. The investigators have conducted preliminary studies in humans with IPF and demonstrated a significant increase in \[68Ga\]CBP8 signal in subjects with IPF vs healthy controls. The investigators thus aim to evaluate \[68Ga\]CBP8 in human subjects with radiation induced lung injury and in patients undergoing radiation therapy for pancreatic cancer: To establish the ability of \[68Ga\]CBP8-PET to detect radiation-induced fibrosis in lung or pancreatic cancer patients through the course of disease development with repeated measures, and correlate signal with standard measures of radiation induced tissue injury such as HRCT or MRI.

Conditions

• Lung Cancer
• Radiation Fibrosis
• Radiation Induced Lung Injury
• Pancreas Cancer

Interventions

Type	Name	Description
DRUG	[68Ga]CBP8	Up to 15 mCi of \[68Ga\]CBP8 will be administered to each subject. Each subject will undergo baseline imaging prior to radiation and again 3-6 months after radiation therapy.

Timeline

• Start date: 2020-07-19
• Primary completion: 2027-05-01
• Completion: 2027-07-01
• First posted: 2020-07-24
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study