AminoMedixTM for Kidney Protection During Radionuclide Therapy

NCT ID: NCT05785663

Last Updated: 2023-03-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 28 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-08-08
• Study Completion Date: 2020-03-17

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.

Conditions

Radiation Nephropathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

I

Subjects received Lysine hydrochloride 26 g ± 5% Arginine hydrochlordie 26 g ± 5% Amifostine trihydrate 0.65 g ± 5%

No interventions assigned to this group

II

Subjects received Lysine hydrochloride 39 g ± 5% Arginine hydrochlordie 39 g ± 5% Amifostine trihydrate 0.98 g ± 5%

No interventions assigned to this group

III

Subjects received Lysine hydrochloride 52 g ± 5% Arginine hydrochlordie 52 g ± 5% Amifostine trihydrate 1.3 ± 5%

No interventions assigned to this group

IV

Subjects received Lysine hydrochloride 60 g ± 5% Arginine hydrochlordie 60 g ± 5% Amifostine trihydrate 1.5 ± 5%

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radiomedix, Inc.

INDUSTRY

Sponsor Role: collaborator

Excel Diagnostics and Nuclear Oncology Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

118766

Identifier Type: -

Identifier Source: org_study_id