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Clinical Trials in the USA / NCT06433791
Enrolling by invitation Phase 1

Evaluation of Ascorbate-Meglumine Therapeutic for SRS

NCT06433791 · tracked via the Priya Life Science USA tracker
Sponsor
LadeRx LLC
Phase
Phase 1
Started
2024-09-09
Last updated
2024-09-19

Condition(s) studied

Safety

Investigational drug(s) / intervention(s)

Ascorbate-Meglumine

Ascorbate-Meglumine: Ascorbate, meglumine and sodium salt made by combining 375 mM sodium ascorbate,125 mM ascorbic acid and 125 mM meglumine in sterile water for injection

Study 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)

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Primary cancer diagnosis with newly diagnosed brain metastases * Diagnostic MRI demonstrates the presence of 1 to 3 intact (not previously irradiated or resected) brain metastases. * Maximum tumor diameter ≤ 2.5 cm for the largest lesion determined during the planning MRI * Plan of care must include Stereotactic Radiosurgery (SRS) * SRS treatment plan must be delivered as a single RT fraction * Age 18 years and older * Life expectancy of at least 3 months * GPA score 0.5 or greater * Capable of providing written informed consent to participate in the study Exclusion Criteria: * Primary lesion with radiosensitive histology (i.e., small cell carcinoma, germ-cell tumors, lymphoma, leukemia, and multiple myeloma) * Metastases in the brain stem, pons or medulla or within 3 mm of the optic apparatus (such that some portion of the optic nerve or chiasm would receive a radiation dose \> 10 Gy SRS in one single fraction) * Previous whole-brain radiation (previous SRS to or resection of other brain lesions is permitted if more than 3 months prior to the date of enrollment on this protocol) * Pregnancy * History or manifestation of glucose-6-phosphate dehydrogenase (G6PD) enzyme deficiency * History of oxalate kidney stones * History of iron overload or hemochromatosis * History of allergy to ascorbic acid * Anuria, dehydration, serum albumin \<3.0 g/dL, severe pulmonary congestion or pulmonary edema or fixed low cardiac input since all are conditions for which osmotic diuresis are contraindicated . * Subjects who are on the following drugs and cannot have a drug substitution: flecainide, methadone, amphetamines, quinidine, and chlorpropamide. * Subjects who are on strong inducers, inhibitors or substrates of CYP within 3 days of planned administration of study ascorbate-meglumine. * Subjects for which MRI is contra-indicated (for example a pacemaker/recent surgery with orthopedic prosthesis)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Duke Health Durham North Carolina

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06433791 on ClinicalTrials.gov ↗ ← All trials in the USA