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NCT01962649 · ClinicalTrials.gov registry record · Early Phase 1
A Pilot Study of Optical Molecular Imaging for Percutaneous Biopsy of Hepatocellular Carcinoma Using Indocyanine Green
A Early Phase 1 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
NCT01962649: Completed Early Phase 1 study, sponsored by Massachusetts General Hospital.
NCT01962649 is a Early Phase 1 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 20 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01962649, a Early Phase 1 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
This research study is evaluating an imaging contrast agent called indocyanine green, also known as ICG, in combination with image guided liver biopsies. In this research study, the investigators are looking at the ability of ICG to collect within liver tumors during biopsy. The participant will be receiving a biopsy of their liver as a part of their medical care. By participating in this trial, the only additional requirement will be for the participant to come to the hospital on the day prior to their scheduled biopsy to receive an injection of ICG. During the biopsy, the investigator will measure the amount of ICG that is in the participant's liver tumor by using two experimental devices designed by the study investigators that shine light on tissue. One device consists of an imaging system attached to a small borescope that will go inside the participant's body during the biopsy. The second device shines light on the biopsy sample outside of the participant's body after the biopsy has been taken. The participant may undergo imaging with one or both of these devices.
Primary Outcome
We hypothesize that HCC lesions will have significantly higher fluorescence intensity following ICG administration that normal/cirrhotic liver parenchyma. This will allow the proceduralist to recognize during the procedure whether the target lesion has been sampled accurately. We also hypothesize that OMI will characterize malignant lesions with \>90% accuracy prior to core biopsy, with standard of care histology and follow up imaging as the gold standard. Benign and malignant lesions will have
Interventions
- BIOLOGICAL ICG
- DEVICE Optical molecular imaging
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2013-10 |
| Est. Completion | 2014-04 |
| Phase | Early Phase 1 |
What the finished NCT01962649 record still lists
NCT01962649 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which ICG is the first listed.
NCT01962649 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01962649 about?
NCT01962649 is a clinical study titled "A Pilot Study of Optical Molecular Imaging for Percutaneous Biopsy of Hepatocellular Carcinoma Using Indocyanine Green". This research study is evaluating an imaging contrast agent called indocyanine green, also known as ICG, in combination with image guided liver biopsies. In this research study, the investigators are looking at the ability of ICG to collect within liver tumors during biopsy. The participant will be...
What is the current status of trial NCT01962649?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2013-10. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01962649?
The interventions under investigation include: ICG (BIOLOGICAL), Optical molecular imaging (DEVICE).
Who is sponsoring clinical trial NCT01962649?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01962649's enrollment target sits among peer trials
20 1157th of 2000 higher than 709 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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