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| Name | Class |
|---|---|
| Radiomedix, Inc. | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | Subjects received Lysine hydrochloride 26 g ± 5% Arginine hydrochlordie 26 g ± 5% Amifostine trihydrate 0.65 g ± 5% | ||
| II | Subjects received Lysine hydrochloride 39 g ± 5% Arginine hydrochlordie 39 g ± 5% Amifostine trihydrate 0.98 g ± 5% | ||
| III | Subjects received Lysine hydrochloride 52 g ± 5% Arginine hydrochlordie 52 g ± 5% Amifostine trihydrate 1.3 ± 5% | ||
| IV | Subjects received Lysine hydrochloride 60 g ± 5% Arginine hydrochlordie 60 g ± 5% Amifostine trihydrate 1.5 ± 5% |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of kidney radiation dosimetry in subjects with and without AminoMedix™ using 68Ga-DOTATATE PET/CT imaging as a surrogate marker for 177Lu-DOTATATE™ | Dosimetry results of 68Ga-DOTATATE in subjects, with and without AminoMedixTM will be compared. Each Subject will be imaged with and without AminoMedixTM 24 hours to 3 weeks apart and the reduction ratio will be calculated | 24 hours to 3 weeks between two dosimetry |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and Severity of Adverse Events after AminoMedix™ infusion | Frequency and severity of treatment-related adverse events as assessed by CTCAE v4.0" in subjects after AminoMedix™ infusion | Subjects will be followed for two weeks following administration of AminoMedix™ |
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Inclusion Criteria:
Exclusion Criteria:
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Patient receiving peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-DOTATATE in patients with neuroendocrine cancers.
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