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NCT01789827 · ClinicalTrials.gov registry record · Early Phase 1
Aldesleukin Imaging in Viewing Tumor Growth in Patients With Stage IV Melanoma Receiving Ipilimumab or Pembrolizumab Therapy
A Early Phase 1 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 5
- Enrollment target
NCT01789827: Completed Early Phase 1 study, sponsored by Mayo Clinic.
NCT01789827 is a Early Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 5 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01789827, a Early Phase 1 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
This pilot clinical trial studies aldesleukin imaging in viewing tumor growth in patients with stage IV melanoma receiving ipilimumab or pembrolizumab therapy. Diagnostic procedures, such as single-photon emission computed tomography (SPECT), uses radioactive drugs and a scanner to make detailed pictures of areas inside the body and may be a less invasive way to check for stage IV melanoma. Radioactive drugs, such as technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2, carry radiation directly to cancer cells and may be able to differentiate between tumor growth due to inflammation versus tumor progression in patients with stage IV melanoma receiving therapy.
Primary Outcome
SLTs include grade 2+ allergic reaction, grade 3+ anaphylaxis, grade 2+ injection site reaction, or grade 3+ non-hematologic toxicity (not attributed to immunotherapy treatment/progression or a co-morbid condition). A 95% binomial confidence interval of the proportion of patients who develop a grade 2+ allergic reaction, grade 3+ anaphylaxis, or grade 2+ injection site reaction will be constructed.
Interventions
- OTHER Laboratory Biomarker Analysis
- PROCEDURE Radionuclide Imaging
- BIOLOGICAL Technetium Tc 99 Hydrazinonicotinamide-Tricine-linked Interleukin-2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2014-03 |
| Est. Completion | 2018-06-27 |
| Phase | Early Phase 1 |
What the finished NCT01789827 record still lists
NCT01789827 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01789827 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01789827 about?
NCT01789827 is a clinical study titled "Aldesleukin Imaging in Viewing Tumor Growth in Patients With Stage IV Melanoma Receiving Ipilimumab or Pembrolizumab Therapy". This pilot clinical trial studies aldesleukin imaging in viewing tumor growth in patients with stage IV melanoma receiving ipilimumab or pembrolizumab therapy. Diagnostic procedures, such as single-photon emission computed tomography (SPECT), uses radioactive drugs and a scanner to make detailed pic...
What is the current status of trial NCT01789827?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 5 participants. The study started on 2014-03. Estimated completion is 2018-06-27.
What interventions are being tested in trial NCT01789827?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Radionuclide Imaging (PROCEDURE), Technetium Tc 99 Hydrazinonicotinamide-Tricine-linked Interleukin-2 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01789827?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01789827's enrollment target sits among peer trials
5 1888th of 2000 higher than 80 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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