Evaluation of the Safety and Efficacy of Abenacianine (VGT-309) to Identify Cancer in Subjects Undergoing Surgery for Cancer in the Lung
Recruiting
Phase 3
Interventional Study
Lung Cancer
Lung Metastases
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 132 (estimated)
- Sponsor
- Vergent Bioscience, Inc. · Industry
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About This Trial
This is a Phase 3, multi-center, randomized and intrasubject controlled study to evaluate the safety and efficacy of abenacianine for injection, a tumor-targeted, activatable fluorescent imaging agent, to identify cancer using NIR imaging in participants undergoing surgery for cancer in the lung. Approximately 132 partiipants will be enrolled to ensure a minimum of 115 evaluable participants recei…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Be willing and able to sign the informed consent and comply with study procedures.
2. Be at least 18 years of age.
3. Be scheduled for or planning to have a surgical resection of a lung lesion or mass with diagnostic and/or curative intent.
4. Meet all requirements for the pl…
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