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PET/CT Imaging with 124I-AT-01 for Amyloidosis
Phase 2
Waitlist Available
Research Sponsored by University of Tennessee Graduate School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have undergone PET/CT imaging with 124I-AT-01 as part of the AMY1001 study (IND #132282) with visually positive uptake of radiotracer in at least one abdominothoracic organ.
Must have a diagnosis of systemic amyloidosis based on the patient's medical record.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to the end of the study is 8 days
Awards & highlights
Study Summary
This trial will use PET/CT imaging to measure changes in organ-specific amyloid load, to monitor disease response over time.
Who is the study for?
This trial is for individuals with systemic amyloidosis who have previously had PET/CT scans showing amyloid in their organs. They must be able to follow the study plan, not be on dialysis, and women should not be pregnant or breastfeeding. Participants need a history of imaging with 124I-AT-01 over 12 months ago and cannot have iodine allergies or conditions preventing them from lying still for an hour.Check my eligibility
What is being tested?
The study tests if PET/CT scans using a tracer called 124I-AT-01 can track changes in organ-specific amyloid deposits over time. This could help monitor how well treatments are working by measuring the amount of amyloid in different organs.See study design
What are the potential side effects?
Potential side effects may include reactions related to iodine sensitivity, discomfort from lying still during scanning, and general risks associated with exposure to radiation from the imaging process.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had a PET/CT scan with a specific tracer showing positive results in my chest or abdomen.
Select...
I have been diagnosed with systemic amyloidosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from enrollment to the end of the study is 8 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to the end of the study is 8 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To measure visual and quantitative changes in organ-specific uptake of 124I-AT-01
Other outcome measures
Measure of Interest
Measure of interest
Measures of Interest
Side effects data
From 2017 Phase 3 trial • 28 Patients • NCT0007941729%
Neutrophil count decreased
10%
Platelet count decreased
5%
Upper respiratory infection
5%
Urticaria
5%
Catheter related infection
5%
Dehydration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vincristine Sulfate and Carboplatin and Surgery
Trial Design
1Treatment groups
Experimental Treatment
Group I: Patients will receive a single IV injection of 124I-AT-01 radiotracer and PET/CT imagingExperimental Treatment1 Intervention
124I-AT-01 (124I-p5+14, iodine-124I evuzamitide) is an iodine-124 (124I) labeled 45 L-amino acid peptide suitable for PET/CT imaging. The peptide binds many forms of amyloid through multivalent electrostatic interactions with the amyloid fibril and ubiquitous heparan sulfate proteoglycans.
124I-AT-01 has been evaluated previously in an open-label Phase 1/2 clinical trial, AMY1001, performed at the University of Tennessee Medical Center (IND# 132282; NCT T03678259).
In this repeat imaging study, patients previously enrolled in the AMY1001 study, in whom positive PET/CT imaging findings were observed will undergo repeat imaging to assess changes in radiotracer uptake in the liver, spleen, heart and kidneys.
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Who is running the clinical trial?
University of Tennessee Graduate School of MedicineLead Sponsor
12 Previous Clinical Trials
1,104 Total Patients Enrolled
2 Trials studying Amyloidosis
92 Patients Enrolled for Amyloidosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant or breastfeeding, and I am either surgically sterile or post-menopausal.You have had an allergic reaction to iodine (potassium iodide) in the past.You have severe memory problems or other serious mental illnesses.Your body has produced antibodies to the study drug that are significantly higher than normal.I had a PET/CT scan with a specific tracer showing positive results in my chest or abdomen.You must have had a specific type of imaging done for a study more than a year ago before you can have it done again.I have been diagnosed with systemic amyloidosis.I cannot stay still for an hour during a scan.I am currently on dialysis.I am on heparin or similar medications for blood thinning.
Research Study Groups:
This trial has the following groups:- Group 1: Patients will receive a single IV injection of 124I-AT-01 radiotracer and PET/CT imaging
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are opportunities presently available for individuals to enrol in this medical experiment?
"As reported on clinicaltrials.gov, this medical study has ceased recruitment of new patients as it was last updated in July 28th 2023. This initial posting date for the trial had been December 7th 2022. Despite its completion, 103 other studies are currently searching for test subjects to join their trials."
Answered by AI
What safety precautions are being employed to ensure the efficacy of 124I-AT-01 radiotracer and PET/CT imaging?
"There is some evidence that this specific radiotracer 124I-AT-01 and imaging PET/CT are safe, so we have assigned it a score of 2. This medical trial is still in Phase 2, meaning there has yet to be any efficacy data collected from its use."
Answered by AI
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