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NCT05048732 · ClinicalTrials.gov registry record · Early Phase 1
Imaging Apoptosis for Lymphoma Treatment Response
A Early Phase 1 study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 12
- Enrollment target
NCT05048732: Clinical Trial Early Phase 1 study, sponsored by Washington University School of Medicine.
NCT05048732 is a Early Phase 1 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 12 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05048732, a Early Phase 1 study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
Apoptosis is a specific form of cell death that leads to clearance of dead cells without causing inflammation or injury to normal adjacent tissues. Targeted cancer therapeutics that target this pathway for tumor cell death induction are in development, but few specific biomarkers of apoptosis are available to assess treatment response. Apoptosis also occurs in response to standard anthracycline or combination therapies such as rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP), rituximab, etoposide, phosphate, prednisone, vincristine sulfacte, cyclophosphamide, and doxorubicin hydrocholoride (R-EPOCH) used to treat many different histopathological types of lymphoma including Hodgkin and non- Hodgkin lymphoma such as diffuse large B-cell lymphoma (DLBCL), Burkitts lymphoma, primary mediastinal B-cell lymphoma and double hit DLBCL. Caspase-3 activation occurs as a result of apoptosis and may be a specific marker of apoptosis. Therefore, this study will assess whether 18F-FluorApoTrace (18F-FAT), a caspase-3 targeted tracer, has a reasonable dosimetry profile and can be used to detect apoptosis in patients with lymphoma being treated with standard therapy.
Primary Outcome
-The time activity curves will be created using all the scans obtained and integrated to determine organ residence times. This data, plus the counts and volumes from urine collection(s) after tracer injection, will then be used to calculate the dosimetry using OLINDA/EXM v1.1. The calculated residence times will be used with the program OLINDA/EXM for 18F and using the adult human (adult female or male) model to calculate the whole body effective dose.
Interventions
- DRUG 18F-FluorApoTrace
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2021-12-06 |
| Est. Completion | 2024-02-10 |
| Phase | Early Phase 1 |
Why NCT05048732 stopped before completion
NCT05048732 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which 18F-FluorApoTrace is the first listed.
NCT05048732 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05048732 about?
NCT05048732 is a clinical study titled "Imaging Apoptosis for Lymphoma Treatment Response". Apoptosis is a specific form of cell death that leads to clearance of dead cells without causing inflammation or injury to normal adjacent tissues. Targeted cancer therapeutics that target this pathway for tumor cell death induction are in development, but few specific biomarkers of apoptosis are av...
What is the current status of trial NCT05048732?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2021-12-06. Estimated completion is 2024-02-10.
What interventions are being tested in trial NCT05048732?
The interventions under investigation include: 18F-FluorApoTrace (DRUG).
Who is sponsoring clinical trial NCT05048732?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05048732's enrollment target sits among peer trials
12 1529th of 2000 higher than 401 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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