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NCT06828588 · ClinicalTrials.gov registry record · Early Phase 1
Pilot Study of [68Ga]Ga-ABY-025 Imaging in Patients Undergoing Treatment With HER2-targeted Therapy
A Early Phase 1 study, sponsored by Vanderbilt-Ingram Cancer Center.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 30
- Enrollment target
NCT06828588: Recruiting Early Phase 1 study, sponsored by Vanderbilt-Ingram Cancer Center.
NCT06828588 is a Early Phase 1 study that is actively recruiting participants, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 30 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06828588, a Early Phase 1 study, is actively recruiting participants, sponsored by Vanderbilt-Ingram Cancer Center.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if the radiotracer, \[68Ga\]Ga-ABY-025, used for PET imaging can help us better identify and visualize lesions or tumors, in patients who are receiving standard of care therapy HER2+ cancers.
Primary Outcome
Outcome Measure: After study enrollment, subjects will receive \[68Ga\]Ga-ABY-025 infusion and undergo PET/CT scan. Patients will be immediately assessed for adverse events within the first 30 minutes of infusion and 2-7 days post-infusion from the study coordinator. Adverse events will be monitored up to 21±14 days following the infusion of study drug. Repeat infusion and imaging will be obtained either at the time of treatment discontinuation or at 12 months from study consent and will have th
Interventions
- DRUG [68Ga]Ga-ABY-025
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2026-04-16 |
| Est. Completion | 2029-12 |
| Phase | Early Phase 1 |
What NCT06828588 shows while recruiting
NCT06828588 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 1 intervention - of which [68Ga]Ga-ABY-025 is the first listed.
NCT06828588 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06828588 about?
NCT06828588 is a clinical study titled "Pilot Study of [68Ga]Ga-ABY-025 Imaging in Patients Undergoing Treatment With HER2-targeted Therapy". The purpose of this study is to determine if the radiotracer, \[68Ga\]Ga-ABY-025, used for PET imaging can help us better identify and visualize lesions or tumors, in patients who are receiving standard of care therapy HER2+ cancers.
What is the current status of trial NCT06828588?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 30 participants. The study started on 2026-04-16. Estimated completion is 2029-12.
What interventions are being tested in trial NCT06828588?
The interventions under investigation include: [68Ga]Ga-ABY-025 (DRUG).
Who is sponsoring clinical trial NCT06828588?
This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 189 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06828588's enrollment target sits among peer trials
30 807th of 2000 higher than 1,075 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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