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99mTc-p5+14 Imaging for Amyloidosis
Phase 1
Recruiting
Led By Jonathan S Wall, PhD
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
Have a confirmed diagnosis of systemic AL amyloidosis or systemic ATTR amyloidosis with specific diagnostic criteria
Does not have a diagnosis of amyloidosis nor has a first- or second-degree relative with confirmed or suspected familial amyloidosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to the end of study is 8 days
Awards & highlights
Study Summary
This trial will test a new radiopharmaceutical to detect amyloid deposits in patients with heart problems.
Who is the study for?
This trial is for adults over 18 with confirmed systemic AL or ATTR amyloidosis, particularly affecting the heart. Participants must be in good health, understand and consent to study procedures, and women of childbearing potential must test negative for pregnancy. Exclusions include severe allergies, certain heart conditions, liver issues, claustrophobia preventing imaging protocol completion, dialysis patients, pregnant or breastfeeding individuals.Check my eligibility
What is being tested?
The study tests a synthetic peptide called 99mTc-p5+14 labeled with technetium-99m as a radiotracer to detect amyloid deposits in patients with cardiac involvement due to AL or ATTR-associated systemic amyloidosis. It aims to assess the effectiveness of this new diagnostic tool.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include reactions related to the infusion of radiolabeled peptides such as allergic reactions or discomfort at the injection site. As it's an investigational procedure involving radiation exposure from technetium-99m, there might also be risks associated with radiation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with AL or ATTR amyloidosis.
Select...
I do not have amyloidosis, nor does my close family.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from enrollment to the end of study is 8 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to the end of 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
Whole body effective dosimetry measurement
Secondary outcome measures
Measure cardiac uptake of 99mTc-p5+14 radioactivity from planar and SPECT/CT images in comparison to 99mTc-PYP uptake
Measure uptake of 99mTc-p5+14 radioactivity in extracardiac tissues from planar and SPECT/CT images
Other outcome measures
Compare planar and SPECT imaging of 99mTc-p5+14 for the detection of cardiac amyloid
Trial Design
2Treatment groups
Experimental Treatment
Group I: Estimation of dosimetry for 99mTc-p5+14 and Biodistribution Of 99mtc-p5+14 In Healthy SubjectsExperimental Treatment1 Intervention
For dosimetry, patients with a confirmed diagnosis of systemic AL amyloidosis, patients will be administered a single IV dose of up to 1 mg of 99mTc-p5+14 (~20 mCi) by slow push (~1 mL/5 sec.). Patients will then undergo serial planar scintigraphic imaging at ~30 minutes, ~1 hour, ~2 hours, ~4 hours, ~6 hours, and ~24 hours post-injection. At the 4-hour time point, the patient will also undergo a single SPECT/CT scan to provide additional data for estimating dosimetry. Before injection of the radiotracer and at each imaging session, ~2 -3 mL of blood will be acquired to determine the whole blood radioactivity.
Healthy volunteers will undergo an echo examination, thereafter, they will be administered a single IV dose of 99mTc-p5+14 (20 mCi) and will undergo a single planar image acquisition followed by SPECT/CT imaging at ~1 hour and ~3 hours post-injection.
Group II: Biodistribution in patients with systemic AL or ATTR amlyoidosisExperimental Treatment1 Intervention
Patients with a confirmed diagnosis of systemic AL or ATTR (with or without a positive PyP scan) will be administered a single IV dose of up to 1 mg of 99mTc-p5+14 (~20 mCi) by slow push (~1 mL/5 sec.). At ~1 hour and ~3 hours post-injection, patients will undergo abdominothoracic planar imaging followed by SPECT/CT imaging covering the same area. Vital signs (blood pressure, respiration rate, temperature, and pulse) will be acquired before injection of the 99mTc-p5+14, and at ~3 hours post injection.
On Day 3, patient will undergo a trans thoracic echo examination. On Day 4, patients will undergo Technescan™ 99mTc-PYP (20 mCi) planar and SPECT/CT imaging at ~1 hour and ~3 hours post-injection. Vital signs (blood pressure, respiration rate, temperature, and pulse) will be acquired before injection of the 99mPYP, and at ~3 hours post injection.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
University of Tennessee Graduate School of MedicineLead Sponsor
12 Previous Clinical Trials
1,089 Total Patients Enrolled
2 Trials studying Amyloidosis
77 Patients Enrolled for Amyloidosis
Attralus, Inc.Industry Sponsor
6 Previous Clinical Trials
315 Total Patients Enrolled
6 Trials studying Amyloidosis
315 Patients Enrolled for Amyloidosis
Jonathan S Wall, PhDPrincipal InvestigatorUniversity of Tennessee Graduate School of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to use birth control if there's any chance of pregnancy with my partner.I have taken heparin or similar drugs in the last week.I am a woman who can have children and have a recent negative pregnancy test.You are allergic to potassium iodide.Your blood tests showed high levels of AST and bilirubin in the past six months.I do not have any health conditions that could interfere with the study or increase my risk.I have been diagnosed with AL or ATTR amyloidosis.I have received p5+14 treatment before.I do not have any mental health issues that would prevent me from participating.I do not have amyloidosis, nor does my close family.I am older than 18 years.Your liver blood tests showed high levels of ALT and bilirubin in the past six months.You have extreme fear of enclosed spaces or any medical condition that would make it difficult to complete the imaging process.I am currently on dialysis.I was diagnosed with cardiac amyloidosis less than 2 years ago.My heart's electrical cycle is longer than normal.You cannot have participated in another clinical trial involving nuclear medicine amyloid imaging and received a tracer injection in the last 6 months.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Biodistribution in patients with systemic AL or ATTR amlyoidosis
- Group 2: Estimation of dosimetry for 99mTc-p5+14 and Biodistribution Of 99mtc-p5+14 In Healthy Subjects
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 there any available spots for participation in this experiment?
"Indeed, the clinicaltrials.gov database displays that recruitment is open for this experiment. It was initially made public on July 1st 2023 and last modified on July 10th of the same year. 35 test subjects are required from a single medical centre to complete this trial."
Answered by AI
Is there potential harm to individuals from Estimation of dosimetry for 99mTc-p5+14 and Biodistribution Of 99mtc-p5+14 In Healthy Subjects?
"Our esteemed experts at Power give Estimation of dosimetry for 99mTc-p5+14 and Biodistribution Of 99mtc-P5+14 In Healthy Subjects a rating of 1 because it is currently in its first phase with little evidence to support safety or efficacy."
Answered by AI
How many individuals have been recruited to participate in this exploration?
"Affirmative. The clinical trial information hosted on clinicaltrials.gov demonstrate that this study, first posted on July 1st 2023, is presently recruiting patients for enrolment. 35 individuals are required from a single location."
Answered by AI
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