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NCT06328686 · ClinicalTrials.gov registry record · Early Phase 1
Arginine and Whole Brain Radiation Therapy for the Treatment of Patients With Brain Metastases
A Early Phase 1 study of Metastatic Malignant Solid Neoplasm and Metastatic Malignant Neoplasm in the Brain, sponsored by Emory University.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT06328686: Recruiting Early Phase 1 study of Metastatic Malignant Solid Neoplasm and Metastatic Malignant Neoplasm in the Brain, sponsored by Emory University.
NCT06328686 is a Early Phase 1 study of Metastatic Malignant Solid Neoplasm and Metastatic Malignant Neoplasm in the Brain that is actively recruiting participants, run by Emory University. The registered enrollment target is 10 participants, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06328686, a Early Phase 1 study of Metastatic Malignant Solid Neoplasm and Metastatic Malignant Neoplasm in the Brain, is actively recruiting participants, sponsored by Emory University.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
This early phase I trial evaluates different administration techniques (oral or intravenous) for arginine and tests the safety of giving arginine with whole brain radiation therapy in patients who have cancer that has spread from where it first started (primary site) to the brain (brain metastases). Arginine is an essential amino acid. Amino acids are the molecules that join together to form proteins in the body. Arginine supplementation has been shown to improve how brain metastases respond to radiation therapy. The optimal dosing of arginine for this purpose has not been determined. This study measures the level of arginine in the blood with oral and intravenous dosing at specific time intervals before and after drug administration to determine the best dosing strategy.
Primary Outcome
By compartmental pharmacokinetic analysis, the plasma arginine levels at before administration, 10 min, 30 min, 1 hour, 2 hours, and 4 hours post administration will be used to estimate the median time to reach the peak plasma arginine and the mean value of peak. This will be done separately by two arms.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- DIETARY_SUPPLEMENT Arginine
- PROCEDURE Spectroscopy
Study Locations (1)
Georgia
- Emory University Hospital/Winship Cancer Institute - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2024-09-05 |
| Est. Completion | 2027-12-31 |
| Phase | Early Phase 1 |
What NCT06328686 shows while recruiting
NCT06328686 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Metastatic Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06328686 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT06328686 about?
NCT06328686 is a clinical study titled "Arginine and Whole Brain Radiation Therapy for the Treatment of Patients With Brain Metastases". This early phase I trial evaluates different administration techniques (oral or intravenous) for arginine and tests the safety of giving arginine with whole brain radiation therapy in patients who have cancer that has spread from where it first started (primary site) to the brain (brain metastases)....
What is the current status of trial NCT06328686?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2024-09-05. Estimated completion is 2027-12-31.
What conditions does trial NCT06328686 study?
This clinical trial studies the following conditions: Metastatic Malignant Solid Neoplasm, Metastatic Malignant Neoplasm in the Brain.
What interventions are being tested in trial NCT06328686?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Arginine (DIETARY_SUPPLEMENT), Spectroscopy (PROCEDURE).
Who is sponsoring clinical trial NCT06328686?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06328686 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06328686's enrollment target sits among peer trials
10 92nd of 92 the lowest of 92 other Metastatic Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Malignant Solid Neoplasm 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.
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