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AminoMedixTM for Kidney Protection During Radionuclide Therapy

NCT05785663 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 28

Last updated 2023-03-27

No results posted yet for this study

Summary

This is a phase I, and II, single-center, open-label clinical trial to evaluate the safety and preliminary efficacy information of AminoMedix™ in protecting kidneys from radiation-induced toxicity during Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-DOTATATE in patients with neuroendocrine cancers.

Aims of the study:

1. Evaluation of the safety of AminoMedix ™ infusion.
2. Evaluation of kidney radiation dosimetry with and without AminoMedix™ using 68Ga-DOTATATE PET/CT imaging as a surrogate marker for 177Lu-DOTATATE.
3. Evaluation of the safety and calculation of kidney and tumor radiation dosimetry after AminoMedix™ infusion with low dose 177Lu-DOTATATE in patients with neuroendocrine cancers.

Conditions

  • Radiation Nephropathy

Sponsors & Collaborators

  • Radiomedix, Inc.

    collaborator INDUSTRY

  • Excel Diagnostics and Nuclear Oncology Center

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-08
Primary Completion
2016-09-28
Completion
2020-03-17

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05785663 on ClinicalTrials.gov