Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06433791
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-30
First Post:
2024-05-20
Brief Title:
Evaluation of Ascorbate-Meglumine Therapeutic for SRS
Sponsor:
LadeRx LLC
Organization:
LadeRx LLC
Study Overview
Official Title:
Phase 1 Single-Center Dose-Escalating Open-Label Safety Clinical Trial of Parenteral Ascorbate-Meglumine As a Novel Magnetic Resonance Imaging MRI-guided Adjunctive Therapeutic for Stereotactic Radiosurgery SRS
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase 1 Single-Center Dose-Escalating Open-Label Safety Clinical Trial of Parenteral Ascorbate-Meglumine as a Novel Magnetic Resonance Imaging MRI-guided Adjunctive Therapeutic for Stereotactic Radiosurgery SRS
Detailed Description:
Phase 1 single-center open-label study in subjects receiving Stereotactic Radiosurgery SRS for brain metastases The study will consist of 4 principal cohorts n3 in each cohort Each cohort will receive an escalating dose of ascorbate-meglumine as an Magnetic Resonance Imaging MRI-detectable adjunctive therapeutic to SRS
Subjects will complete a planning MRI for SRS with gadolinium- diethylenetriamine penta-acetic acid GD-DPTA per standard of care for SRS Forty-eight hours after the planning MRI the subjects will complete the study MRI with ascorbate-meglumine contrast agent Each cohort will receive an escalating dose of ascorbate-meglumine by intravenous administration over 1 hour during the MRI The total dose of ascorbate-meglumine will escalate from the first cohort to the next cohort in a sequential manner During ascorbate-meglumine infusion MRI scans will be performed to evaluate the contrast effect and PK blood draws will occur at defined time points
Patients will return for the SRS procedure within 1 week following the planning MRI per standard of care During SRS subjects will receive a second dose of ascorbate-meglumine as an adjunctive therapeutic
Patients will enter into a follow up phase within 2 weeks after the SRS procedure per standard of care
The primary endpoint is to evaluate the safety of parenteral ascorbate-meglumine as a MRI-detectable adjunctive therapeutic to SRS
Subjects will complete a planning MRI for SRS with gadolinium- diethylenetriamine penta-acetic acid GD-DPTA per standard of care for SRS Forty-eight hours after the planning MRI the subjects will complete the study MRI with ascorbate-meglumine contrast agent Each cohort will receive an escalating dose of ascorbate-meglumine by intravenous administration over 1 hour during the MRI The total dose of ascorbate-meglumine will escalate from the first cohort to the next cohort in a sequential manner During ascorbate-meglumine infusion MRI scans will be performed to evaluate the contrast effect and PK blood draws will occur at defined time points
Patients will return for the SRS procedure within 1 week following the planning MRI per standard of care During SRS subjects will receive a second dose of ascorbate-meglumine as an adjunctive therapeutic
Patients will enter into a follow up phase within 2 weeks after the SRS procedure per standard of care
The primary endpoint is to evaluate the safety of parenteral ascorbate-meglumine as a MRI-detectable adjunctive therapeutic to SRS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None