NCT03535545

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

Recruiting now Phase 1 Last updated 27 February 2026

What this trial tests

Phase 1 trial testing [68Ga]CBP8 in Pulmonary Fibrosis in 100 participants. Currently enrolling.

Timeline

1 August 2018

Primary endpoint
30 June 2027

30 June 2027

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	diagnostic
Enrollment	100
Start date	1 August 2018
Primary completion	30 June 2027
Estimated completion	30 June 2027
Sites	1 location across United States

Drugs / interventions tested

• [68Ga]CBP8 — full drug profile →
• PET Imaging

Conditions studied

• Pulmonary Fibrosis — all drugs for Pulmonary Fibrosis →
• Lung Cancer — all drugs for Lung Cancer →

Sponsor

Massachusetts General Hospital

Who can join

Adults 18 to 80, any sex, with Pulmonary Fibrosis or Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Molecular imaging of fibrosis: recent advances and future directions.
   Montesi SB, Désogère P, Fuchs BC, Caravan P. · · 2019 · cited 96× · PMID 30601139 · DOI 10.1172/jci122132
2. Biomarker-driven molecular imaging probes in radiotherapy.
   Li H, Gong Q, Luo K. · · 2024 · cited 77× · PMID 38994026 · DOI 10.7150/thno.97768
3. Type I Collagen-targeted Positron Emission Tomography Imaging in Idiopathic Pulmonary Fibrosis: First-in-Human Studies.
   Montesi SB, Izquierdo-Garcia D, Désogère P, Abston E, et al · · 2019 · cited 65× · PMID 31161770 · DOI 10.1164/rccm.201903-0503le
4. Biodistribution, Dosimetry, and Pharmacokinetics of <sup>68</sup>Ga-CBP8: A Type I Collagen-Targeted PET Probe.
   Izquierdo-Garcia D, Désogère P, Fur ML, Shuvaev S, et al · · 2023 · cited 24× · PMID 37116909 · DOI 10.2967/jnumed.122.264530
5. Novel Imaging Approaches in Systemic Sclerosis-Associated Interstitial Lung Disease.
   Montesi SB, Caravan P. · · 2019 · cited 14× · PMID 31025121 · DOI 10.1007/s11926-019-0826-9
6. Collagen type I PET/MRI enables evaluation of treatment response in pancreatic cancer in pre-clinical and first-in-human translational studies.
   Esfahani SA, Ma H, Krishna S, Shuvaev S, et al · · 2024 · cited 13× · PMID 39346545 · DOI 10.7150/thno.100116
7. Radiotracers for Imaging of Fibrosis: Advances during the Last Two Decades and Future Directions.
   Eriksson O, Velikyan I. · · 2023 · cited 8× · PMID 38004406 · DOI 10.3390/ph16111540
8. Noninvasive Quantification of Radiation-Induced Lung Injury using a Targeted Molecular Imaging Probe
   Abston E, Zhou IY, Saenger JA, Shuvaev S, et al · · 2023 · DOI 10.1101/2023.09.25.23295897