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

NCT03535545 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 2017P002718R01HL153606
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pulmonary Fibrosis; Lung Cancer

Keywords

PET Imaging; Molecular Imaging

Outcome Measures

Primary Outcomes (1)

• Ability to detect increased collagen deposition in pulmonary 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.

  Two hours

Secondary Outcomes (1)

• Ability of the degree of collagen deposition to predict disease progression.

  Up to 36 months

Other Outcomes (1)

• Ability of [68Ga]CBP8 to detect collagen deposition in areas of radiation injury.

  Up to 3 months

Study Arms (5)

Healthy Individuals

EXPERIMENTAL

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

Drug: [68Ga]CBP8; Diagnostic Test: PET Imaging

Lung Cancer Subjects

EXPERIMENTAL

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

Drug: [68Ga]CBP8; Diagnostic Test: PET Imaging

Pulmonary Fibrosis Subjects

EXPERIMENTAL

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.

Drug: [68Ga]CBP8; Diagnostic Test: PET Imaging

Subjects with chronic lung allograft dysfunction (CLAD)

EXPERIMENTAL

Subjects with chronic lung allograft dysfunction (CLAD) will receive \[68Ga\]CBP8 and undergo PET imaging.

Drug: [68Ga]CBP8; Diagnostic Test: PET Imaging

Subjects with immune-checkpoint-inhibitor (ICI) pneumonitis

EXPERIMENTAL

Subjects with immune-checkpoint-inhibitor (ICI) pneumonitis will receive \[68Ga\]CBP8 and undergo PET imaging.

Drug: [68Ga]CBP8; Diagnostic Test: PET Imaging

Interventions

[68Ga]CBP8 DRUG

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

Healthy Individuals; Lung Cancer Subjects; Pulmonary Fibrosis Subjects; Subjects with chronic lung allograft dysfunction (CLAD); Subjects with immune-checkpoint-inhibitor (ICI) pneumonitis

PET Imaging DIAGNOSTIC_TEST

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

Healthy Individuals; Lung Cancer Subjects; Pulmonary Fibrosis Subjects; Subjects with chronic lung allograft dysfunction (CLAD); Subjects with immune-checkpoint-inhibitor (ICI) pneumonitis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Group 1: Healthy subjects
• Age greater than 18 years
• Be deemed healthy at screening visit as determined by the physician investigator or nurse practitioner, based on the following assessments at Screening: physical examination, medical history, and vital signs
• Have the ability to give written informed consent;
• No known history of pulmonary disease (excluding pulmonary nodules);
• No prior history of tobacco use.
• Group 2: Lung cancer subjects
• Eligible patients will be those harboring locally advanced clinical stage IIIA NSCLC who are deemed candidates for multi-modality therapy, i.e. concurrent chemotherapy and radiation followed by pulmonary resection.
• Age greater than 18 years
• Have the ability to give written informed consent.
• No tobacco use within the prior 6 months.
• Group 3: Subjects with pulmonary fibrosis
• IPF (with a UIP or probable UIP pattern); or other forms of interstitial lung disease (ILD), including CTD-ILD, with a fibrotic component as noted by the presence of reticular markings and / or traction bronchiectasis and / or honeycombing on CT;
• Age: 40-80 years old;
• Have the ability to give written informed consent;

You may not qualify if:

• Electrical implants such as cardiac pacemaker or perfusion pump;
• Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, metallic tattoos anywhere on the body, tattoos near the eye, or steel implants ferromagnetic objects such as jewelry or metal clips in clothing;
• eGFR of less than 30 mL/min/1.73 m2 within the past 90 days for group 4 subjects; history of chronic kidney disease for subjects in groups 1-3 and 5;
• Pregnant or breastfeeding (a negative quantitative serum hCG pregnancy test is required for females having child-bearing potential before the subject can participate);
• Claustrophobic reactions;
• Research-related radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months);
• Unable to lie comfortably on a bed inside the MR-PET;
• BMI \> 33 (limit of the MRI table);
• Determined by the investigator(s) to be clinically unsuitable for the study (e.g. based on screening visit and/or during study procedures);
• Known history of pulmonary disease (except for pulmonary fibrosis in the study group, ICI pneumonitis in the study group, or CLAD in the study group), recent pneumonia or respiratory tract infections within 6 weeks of enrollment, prior radiation therapy to the thorax (except for the lung cancer patients in aim 2);
• Pneumonia or other acute respiratory illness within 6 weeks of study entry (except for pulmonary fibrosis), pneumonia defined with elevated WBC, fever, infiltrate on CXR and need for antibiotics

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (5)

• Desogere P, Tapias LF, Hariri LP, Rotile NJ, Rietz TA, Probst CK, Blasi F, Day H, Mino-Kenudson M, Weinreb P, Violette SM, Fuchs BC, Tager AM, Lanuti M, Caravan P. Type I collagen-targeted PET probe for pulmonary fibrosis detection and staging in preclinical models. Sci Transl Med. 2017 Apr 5;9(384):eaaf4696. doi: 10.1126/scitranslmed.aaf4696.

  PMID: 28381537 BACKGROUND

• Desogere P, Tapias LF, Rietz TA, Rotile N, Blasi F, Day H, Elliott J, Fuchs BC, Lanuti M, Caravan P. Optimization of a Collagen-Targeted PET Probe for Molecular Imaging of Pulmonary Fibrosis. J Nucl Med. 2017 Dec;58(12):1991-1996. doi: 10.2967/jnumed.117.193532. Epub 2017 Jun 13.

  PMID: 28611243 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.

  PMID: 31161770 RESULT

• 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.

  PMID: 37116909 RESULT

• Abston E, Zhou IY, Saenger JA, Shuvaev S, Akam E, Esfahani SA, Hariri LP, Rotile NJ, Crowley E, Montesi SB, Humblet V, Arabasz G, Catana C, Fintelmann FJ, Caravan P, Lanuti M. Noninvasive Quantification of Radiation-Induced Lung Injury using a Targeted Molecular Imaging Probe. medRxiv [Preprint]. 2023 Sep 26:2023.09.25.23295897. doi: 10.1101/2023.09.25.23295897.

  PMID: 37808864 DERIVED

MeSH Terms

Conditions

Pulmonary Fibrosis; Lung Neoplasms

Interventions

Positron-Emission Tomography

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Sydney B Montesi, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sydney B Montesi, MD

CONTACT

617 724 4030; sbmontesi@partners.org

Abimbola Akinniyi

CONTACT

781 513 0207; aakinniyi@mgb.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology

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

Study Record Dates

• First Submitted: May 11, 2018
• First Posted: May 24, 2018
• Study Start: August 1, 2018
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)