Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Lung Neoplasms

Fibrosis

Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Lung Diseases, Interstitial

Healthy volunteers will receive \[68Ga\]CBP8 and undergo PET imaging.

Lung cancer patients will receive \[68Ga\]CBP8 and undergo PET imaging.

Idiopathic pulmonary fibrosis patients or patients with other types of interstitial lung disease with a fibrotic component will receive \[68Ga\]CBP8 and undergo PET imaging.

Up to 15 mCi of \[68Ga\]CBP8 will be administered to each subject.

[68Ga]CBP8

All subjects will undergo PET imaging after administration of \[68Ga\]CBP8.

PET Imaging

Sydney B Montesi, MD

Layla Rahimi

Sydney Montesi, MD

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

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.

Healthy control subjects will be enrolled first and then subjects with lung cancer and idiopathic pulmonary fibrosis or other types of interstitial lung disease with a fibrotic component meeting inclusion criteria.

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

Probe lung uptake will be measured in lung cancer patients prior to surgical resection and compared to histologic measures of fibrosis.

Probe lung uptake will be measured in pulmonary fibrosis subjects and compared to lung uptake in healthy volunteers. We expect greater uptake in the lungs of IPF patients and patients with other types of ILD with a fibrotic component.

Probe lung uptake in pulmonary fibrosis patients will be correlated with change in forced vital capacity over the prior 12 months and prospectively over the following 12-36 months.

National Heart, Lung, and Blood Institute (NHLBI)

Massachusetts General Hospital

Professor of Radiology

Digestive System Diseases

Gland and Hormone Related Diseases

Wounds and Injuries

Pancreatic Neoplasms

Lung Injury

Radiation Fibrosis Syndrome

Syndrome

Thoracic Injuries

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Radiation Injuries

Pancreatic Cancer

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

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.

Michael Lanuti, MD

Shadi Esfahani, MD

Eric Abston, MD

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

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.

Eligible subjects planning on receiving radiation for lung cancer or pancreatic cancer will be enrolled to undergo imaging with the PET Probe \[68Ga\]CBP8.

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

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Preliminary Evaluation of [68Ga]CBP8 in Healthy Individuals, Lung Cancer, and Idiopathic Pulmonary Fibrosis Patients	NCT03535545	Pulmonary Fibro... Lung Cancer	[68Ga]CBP8 PET Imaging	18 Years - 80 Years	Massachusetts General Hospital
Evaluation of PET Probe [68Ga]CBP8 in the Detection of Radiation Induced Tissue Injury	NCT04485286	Lung Cancer Radiation Fibro... Radiation Induc... Pancreas Cancer	[68Ga]CBP8	18 Years - 80 Years	Massachusetts General Hospital
Evaluation of PET Probe [68Ga]CBP8 in the Detection of Radiation Induced Tissue Injury	NCT04485286	Lung Cancer Radiation Fibro... Radiation Induc... Pancreas Cancer	[68Ga]CBP8	18 Years - 80 Years	Massachusetts General Hospital

Spots Global Cancer Trial Database for [68ga]cbp8

Every month we try and update this database with for [68ga]cbp8 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for [68ga]cbp8

Every month we try and update this database with for [68ga]cbp8 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for [68ga]cbp8 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.