AminoMedixTM for Kidney Protection During Radionuclide Therapy

AminoMedixTM for Radiation Kidney Protection During Peptide-Receptor Radionuclide Therapy (PRRT): Phase I, II Clinical Trial

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05785663

Enrollment

Registered

2023-03-27

Start date

2014-08-08

Completion date

2020-03-17

Last updated

2023-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiation Nephropathy

Keywords

Radiation nephropathy, PRRT, Radiation induced toxicity, 177Lu-DOTATATE, AminoMedix ™

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients with neuroendocrine tumors are eligible to be recruited in this project. 2. Signed informed consent. 3. Patients of either gender, age 18 years or older. 4. Na+, K+, Cl,: within normal range 5. eGFR: \> 50 mL/min 6. Serum creatinine: \<150μmol/L. Serum creatinine: within normal range or \<120μmol/L for patients aged 60 years or older. 7. Negative pregnancy test (urine test or beta-HCG) in women capable of child-bearing.

Exclusion criteria

1. Known hypersensitivity to Amifostine, Lysine, Arginine, DOTA, 68Gallium, to DOTATATE or to any of the excipients of 68Ga-DOTATATE. 2. Therapeutic use of any somatostatin analogue, including Sandostatin® LAR (within 28 days) and Sandostatin® (within 2 days) prior to study imaging. If a patient is on Sandostatin® LAR a wash-out phase of 28 days is required before the injection of the study drug. 3. Pregnant or breast-feeding women. 4. Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study. 5. Pre-existing cardiovascular or cerebrovascular conditions such as congestive heart failure, ischemic heart disease, arrhythmias, or a history of stroke or transient ischemic attacks. 6. Uncontrolled kidney disease and patients who are under dialysis. 7. Current treatment with potentially nephrotoxic drugs such as aminoglycosides. 8. Less than 24 hours of withdrawal of antihypertensive medications or uncontrolled hypertension, and diabetes at the time of the study. 9. Patients under total or partial parenteral nutrition.

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of kidney radiation dosimetry in subjects with and without AminoMedix™ using 68Ga-DOTATATE PET/CT imaging as a surrogate marker for 177Lu-DOTATATE™	24 hours to 3 weeks between two dosimetry	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

Secondary

Measure	Time frame	Description
Frequency and Severity of Adverse Events after AminoMedix™ infusion	Subjects will be followed for two weeks following administration of AminoMedix™	Frequency and severity of treatment-related adverse events as assessed by CTCAE v4.0 in subjects after AminoMedix™ infusion

Outcome results