NCT03166306: AIPAH

Angiogenic Imaging in Pulmonary Arterial Hypertension

Completed Phase 1, PHASE2 Last updated 6 May 2021

What this trial tests

Phase 1, PHASE2 trial testing PET-CT Imaging with [89Zr]-bevacizumab in Pulmonary Arterial Hypertension in 5 participants. Completed in 31 March 2020.

Timeline

1 May 2018

Primary endpoint
31 October 2019

31 March 2020

Quick facts

Lead sponsor	Brigham and Women's Hospital
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	5
Start date	1 May 2018
Primary completion	31 October 2019
Estimated completion	31 March 2020
Sites	1 location across United States

Drugs / interventions tested

• PET-CT Imaging with [89Zr]-bevacizumab

Conditions studied

• Pulmonary Arterial Hypertension — all drugs for Pulmonary Arterial Hypertension →
• Exercise Associated Pulmonary Arterial Hypertension — all drugs for Exercise Associated Pulmonary Arterial Hypertension →

Sponsor

Brigham and Women's Hospital

Who can join

18 and older, any sex, with Pulmonary Arterial Hypertension or Exercise Associated Pulmonary Arterial Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Pulmonary arterial hypertension (PAH) is a disorder of elevated pulmonary vascular resistance characterized by progressive remodeling and obliteration of vessels of the distal pulmonary circulation. Outcomes in PAH could be improved with earlier diagnosis, and with the early deployment of therapies before irreversible changes have occurred. This study tests the sensitivity of positron emission tomography (PET)-CT scanning with \[89Zr\]-bevacizumab, a radioisotope-conjugated anti-VEGF antibody for detecting pulmonary vascular remodeling in PAH disease. This test could enable non-invasive diagnosis early in the course of the disease, and potentially improve outcomes in PAH,

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. ⁸⁹ Zr-ImmunoPET companion diagnostics and their impact in clinical drug development.
   McKnight BN, Viola-Villegas NT. · · 2018 · cited 41× · PMID 29341222 · DOI 10.1002/jlcr.3605