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

Phase 2

Recruiting

• Conditions: Lung Cancer; Radiation Fibrosis; Radiation Induced Lung Injury; Pancreas Cancer
• Interventions: Drug: [68Ga]CBP8

• Registration Number: NCT04485286
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Study Timeline

• Study Start: 2020-07-19
• Study First Submitted: 2020-07-21
• Study First Submitted QC: 2020-07-21
• Study First Posted: 2020-07-24
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-30
• Last Update Posted: 2023-05-03
• Primary Completion: 2027-05
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lung Cancer or Pancreatic Cancer Subjects Undergoing Radiation Therapy	[68Ga]CBP8	Lung cancer or pancreatic cancer patients will receive \[68Ga\]CBP8 and undergo PET imaging 1) prior to radiation therapy and 2) 3-6 months after radiation therapy

Primary Outcome Measures

Name	Time	Method
Ability of [68Ga]CBP8 to detect collagen deposition in areas of radiation injury.	3-6 Months	Probe uptake will be measured in lung cancer or pancreatic cancer patients 1) prior to radiation therapy and 2) 3-6 months after radiation therapy. We expect \[68Ga\]CBP8 signal to be increased in post radiation measurements over pre-radiation measurements in areas of irradiated tissue. Furthermore we expect that these areas will go on to develop radiation fibrosis.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States