Study Summary
This trial will study if a new imaging agent is safe for use in patients with pulmonary fibrosis and if it can help detect collagen deposition.
Eligible Conditions
- Lung Cancer
- Pulmonary Fibrosis
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: Up to 36 months
Two hours
Ability to detect increased collagen deposition in pulmonary fibrosis.
Up to 3 months
Ability of [68Ga]CBP8 to detect collagen deposition in areas of radiation injury.
Up to 36 months
Ability of the degree of collagen deposition to predict disease progression.
Trial Safety
Safety Progress
Trial Design
3 Treatment Groups
Healthy Individuals
1 of 3
Pulmonary Fibrosis Subjects
1 of 3
Lung Cancer Subjects
1 of 3
Experimental Treatment
100 Total Participants · 3 Treatment Groups
Primary Treatment: PET Imaging · No Placebo Group · Phase 1
Healthy IndividualsExperimental Group · 2 Interventions: PET Imaging, [68Ga]CBP8 · Intervention Types: DiagnosticTest, Drug
Pulmonary Fibrosis SubjectsExperimental Group · 2 Interventions: PET Imaging, [68Ga]CBP8 · Intervention Types: DiagnosticTest, Drug
Lung Cancer SubjectsExperimental Group · 2 Interventions: PET Imaging, [68Ga]CBP8 · Intervention Types: DiagnosticTest, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PET Imaging
2008
Completed Phase 3
~370
Trial Logistics
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 36 months
Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,593 Previous Clinical Trials
46,945,746 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,703 Previous Clinical Trials
30,853,108 Total Patients Enrolled
Sydney B Montesi, MDPrincipal InvestigatorMassachusetts General Hospital
Eligibility Criteria
Age 18 - 80 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Total enrollment for all groups will not exceed 100 subjects.
You must be at least 18 years of age to participate in this study.
You are 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.
References
- Désogère, Pauline, Luis F. Tapias, Tyson A. Rietz, Nicholas Rotile, Francesco Blasi, Helen Day, Justin Elliott, Bryan C. Fuchs, Michael Lanuti, and Peter Caravan. 2017. “Optimization of a Collagen-targeted PET Probe for Molecular Imaging of Pulmonary Fibrosis”. Journal of Nuclear Medicine. Society of Nuclear Medicine. doi:10.2967/jnumed.117.193532.
- Désogère, Pauline, Luis F. Tapias, Lida P. Hariri, Nicholas J. Rotile, Tyson A. Rietz, Clemens K. Probst, Francesco Blasi, et al.. 2017. “Type I Collagen–targeted PET Probe for Pulmonary Fibrosis Detection and Staging in Preclinical Models”. Science Translational Medicine. American Association for the Advancement of Science (AAAS). doi:10.1126/scitranslmed.aaf4696.
- Montesi, Sydney B., David Izquierdo-Garcia, Pauline Désogère, Eric Abston, Lloyd L. Liang, Subba Digumarthy, Ravi Seethamraju, Michael Lanuti, Peter Caravan, and Ciprian Catana. 2019. “Type I Collagen–targeted Positron Emission Tomography Imaging in Idiopathic Pulmonary Fibrosis: First-in-human Studies”. American Journal of Respiratory and Critical Care Medicine. American Thoracic Society. doi:10.1164/rccm.201903-0503le.
- Montesi, Sydney B., David Izquierdo-Garcia, Pauline Désogère, Eric Abston, Lloyd L. Liang, Subba Digumarthy, Ravi Seethamraju, Michael Lanuti, Peter Caravan, and Ciprian Catana. 2019. “Type I Collagen–targeted Positron Emission Tomography Imaging in Idiopathic Pulmonary Fibrosis: First-in-human Studies”. American Journal of Respiratory and Critical Care Medicine. American Thoracic Society. doi:10.1164/rccm.201903-0503le.
- 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.
- 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.
- 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.
- Peter Caravan 2018. "Preliminary Evaluation of [68Ga]CBP8 in Healthy Individuals, Lung Cancer, and Idiopathic Pulmonary Fibrosis Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03535545.
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Conditions
Cancer Related
Treatments