AminoMedixTM for Kidney Protection During Radionuclide Therapy

NCT05785663 | Completed DMC

• 1 other identifier: 118766
• Study Type: observational
• Target: 28
• Locations: 0 countries
• Sites: N/A

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. 1.Evaluation of the safety of AminoMedix ™ infusion.
2. 2.Evaluation of kidney radiation dosimetry with and without AminoMedix™ using 68Ga-DOTATATE PET/CT imaging as a surrogate marker for 177Lu-DOTATATE.
3. 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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Frequency and Severity of Adverse Events after AminoMedix™ infusion

  Subjects will be followed for two weeks following administration of AminoMedix™

Study Arms (4)

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%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient receiving peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-DOTATATE in patients with neuroendocrine cancers.

You may qualify if:

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

You may not qualify if:

• Known hypersensitivity to Amifostine, Lysine, Arginine, DOTA, 68Gallium, to DOTATATE or to any of the excipients of 68Ga-DOTATATE.
• 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.
• Pregnant or breast-feeding women.
• Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.
• Pre-existing cardiovascular or cerebrovascular conditions such as congestive heart failure, ischemic heart disease, arrhythmias, or a history of stroke or transient ischemic attacks.
• Uncontrolled kidney disease and patients who are under dialysis.
• Current treatment with potentially nephrotoxic drugs such as aminoglycosides.
• Less than 24 hours of withdrawal of antihypertensive medications or uncontrolled hypertension, and diabetes at the time of the study.
• Patients under total or partial parenteral nutrition.

Sponsors & Collaborators

• Excel Diagnostics and Nuclear Oncology Center: lead
• Radiomedix, Inc.: collaborator

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: March 27, 2023
• Study Start: August 8, 2014
• Primary Completion: September 28, 2016
• Study Completion: March 17, 2020
• Last Updated: March 27, 2023

Record last verified: 2023-03