Clinical trial NCT05785663: AminoMedixTM for Kidney Protection During Radionuclide Therapy
Official title: AminoMedixTM for Radiation Kidney Protection During Peptide-Receptor Radionuclide Therapy (PRRT): Phase I, II Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radiation Nephropathy
Keywords: Radiation nephropathy
PRRT
Radiation induced toxicity
177Lu-DOTATATE
AminoMedix ™
Lead sponsor: Excel Diagnostics and Nuclear Oncology Center
Sponsor class: OTHER
Collaborators: name: Radiomedix, Inc.
First posted: 2023-03-27
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient receiving peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-DOTATATE in patients with neuroendocrine cancers.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of kidney radiation dosimetry in subjects with and without AminoMedix™ using 68Ga-DOTATATE PET/CT imaging as a surrogate marker for 177Lu-DOTATATE™
timeFrame: 24 hours to 3 weeks between two dosimetry
Secondary outcomes:
measure: Frequency and Severity of Adverse Events after AminoMedix™ infusion
timeFrame: Subjects will be followed for two weeks following administration of AminoMedix™
Other outcomes:
Locations:
Study officials:
References: