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

• Register: ClinicalTrials.gov
• Last refreshed on: 11 December 2023
• Main ID: NCT03535545
• Date of registration: 11/05/2018
• Prospective Registration: Yes
• Primary sponsor: Massachusetts General Hospital
• Public title: Preliminary Evaluation of [68Ga]CBP8 in Healthy Individuals, Lung Cancer, and Idiopathic Pulmonary Fibrosis Patients
• Scientific title: 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
• Date of first enrolment: August 1, 2018
• Target sample size: 100
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03535545
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Sydney B Montesi, MD

• Name: Sydney Montesi, MD

• Name: Sydney B Montesi, MD
• Affiliation: Massachusetts General Hospital

Key inclusion & exclusion criteria

Inclusion Criteria: Total enrollment for all groups will not exceed 100 subjects.

- 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;

- No tobacco use within the prior 6 months

Exclusion Criteria:

- 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;

- 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),
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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Lung Cancer

Pulmonary Fibrosis

Intervention(s)

Diagnostic Test: PET Imaging

Drug: [68Ga]CBP8

Primary Outcome(s)

Ability to detect increased collagen deposition in pulmonary fibrosis. [Time Frame: Two hours]

Secondary Outcome(s)

Ability of the degree of collagen deposition to predict disease progression. [Time Frame: Up to 36 months]

Secondary ID(s)

R01HL131907

2017P002718

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Heart, Lung, and Blood Institute (NHLBI)