AminoMedixTM for Kidney Protection During Radionuclide Therapy

E

Excel Diagnostics and Nuclear Oncology Center

Status

Completed

Conditions

Radiation Nephropathy

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT05785663
118766

Details and patient eligibility

About

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

Enrollment

28 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Trial design

28 participants in 4 patient groups

I
Description:
Subjects received Lysine hydrochloride 26 g ± 5% Arginine hydrochlordie 26 g ± 5% Amifostine trihydrate 0.65 g ± 5%
II
Description:
Subjects received Lysine hydrochloride 39 g ± 5% Arginine hydrochlordie 39 g ± 5% Amifostine trihydrate 0.98 g ± 5%
III
Description:
Subjects received Lysine hydrochloride 52 g ± 5% Arginine hydrochlordie 52 g ± 5% Amifostine trihydrate 1.3 ± 5%
IV
Description:
Subjects received Lysine hydrochloride 60 g ± 5% Arginine hydrochlordie 60 g ± 5% Amifostine trihydrate 1.5 ± 5%

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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