Radiation NephropathyNCT05785663
AminoMedixTM for Kidney Protection During Radionuclide Therapy
An observational study of Radiation Nephropathy, run by Excel Diagnostics and Nuclear Oncology Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Nephropathy
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 8 Aug 2014to 17 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient receiving peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-DOTATATE in patients with neuroendocrine cancers.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
About this study
Official title: AminoMedixTM for Radiation Kidney Protection During Peptide-Receptor Radionuclide Therapy (PRRT): Phase I, II Clinical Trial
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.
- Conditions
- Radiation Nephropathy
- Keywords
- Radiation nephropathy, PRRT, Radiation induced toxicity, 177Lu-DOTATATE, AminoMedix ™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours to 3 weeks between two dosimetry
Secondary outcomes (1)
Frequency and Severity of Adverse Events after AminoMedix™ infusion
Frequency and severity of treatment-related adverse events as assessed by CTCAE v4.0" in subjects after AminoMedix™ infusion
Measured: Subjects will be followed for two weeks following administration of AminoMedix™
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start8 Aug 2014
- Primary completion28 Sep 2016
- Study completion17 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Excel Diagnostics and Nuclear Oncology Center
- Sponsor type
- University, hospital or other
- Collaborators
- Radiomedix, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05785663
- Sponsor's protocol ID
- 118766
- Status last verified
- Mar 2023
- First submitted
- 2 Mar 2023
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AminoMedixTM for Radiation Kidney Protection During Peptide-Receptor Radionuclide Therapy (PRRT): Phase I, II Clinical Trial
- ClinicalTrials.gov ID
- NCT05785663
- Acronym / sponsor ID
- 118766
- Conditions
- Radiation Nephropathy
- Keywords
- Radiation nephropathy, PRRT, Radiation induced toxicity, 177Lu-DOTATATE, AminoMedix ™
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Excel Diagnostics and Nuclear Oncology CenterUniversity, hospital or other
- Collaborators
- Radiomedix, Inc.
- Study start
- 8 Aug 2014 (actual)
- Primary completion
- 28 Sep 2016 (actual)
- Study completion
- 17 Mar 2020 (actual)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient receiving peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-DOTATATE in patients with neuroendocrine cancers.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of kidney radiation dosimetry in subjects with and without AminoMedix™ using 68Ga-DOTATATE PET/CT imaging as a surrogate marker for 177Lu-DOTATATE™
Time frame: 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
1 secondary outcome
Frequency and Severity of Adverse Events after AminoMedix™ infusion
Time frame: Subjects will be followed for two weeks following administration of AminoMedix™
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
Related trials for Radiation Nephropathy
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma
RecruitingPhase 2
Positron Emission Tomography (PET) Guided Stereotactic Body Radiation Therapy for the Treatment of Oligoprogressive Non-small Cell Lung Cancer, Melanoma, and Renal Cell Carcinoma
Lung Non-Small Cell Carcinoma, Malignant Solid Neoplasm
RecruitingPhase 2
Radiotherapy in Combination With Checkpoint Inhibition for Patients With Metastatic Kidney Cancer
Metastatic Renal Cell Carcinoma ( mRCC), OligoProgressive Metastatic Disease
Recruiting
Stereotactic Body RadioTherapy With Continuous Tracking for Primary and Secondary Renal Cancer
Renal Cancer, Renal Secondary Cancer
RecruitingPhase 2
Testing the Addition of Stereotactic Radiation Therapy With Immune Therapy for the Treatment of Patients With Unresectable or Metastatic Renal Cell Cancer, SAMURAI Trial
Metastatic Renal Cell Carcinoma, Stage III Renal Cell Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiation Nephropathy, run by Excel Diagnostics and Nuclear Oncology Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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™ (time frame: 24 hours to 3 weeks between two dosimetry). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023.