35 Participants Needed

99mTc-p5+14 Imaging for Amyloidosis

EB
Overseen ByEmily B Martin, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: University of Tennessee Graduate School of Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have received heparin or similar drugs within seven days before the study.

What data supports the effectiveness of the treatment 99mTc-p5+14 for amyloidosis?

Research shows that Tc-99m labeled p5+14 is effective for imaging systemic amyloidosis using SPECT (a type of imaging test), as it has been validated in a mouse model. This suggests it could help in detecting amyloid deposits in patients.12345

Is 99mTc-p5+14 generally safe for humans?

Radiopharmaceuticals, like 99mTc-p5+14, generally have a low rate of side effects, with estimates of 1 to 6 reactions per 100,000 injections. Most reactions are mild, such as rash or nausea, and serious reactions are very rare.678910

How is the 99mTc-p5+14 treatment different from other treatments for amyloidosis?

The 99mTc-p5+14 treatment is unique because it uses a radiolabeled peptide for SPECT imaging to detect amyloid deposits in the body, offering a non-invasive way to visualize and diagnose systemic amyloidosis. Unlike other methods, it can bind to all types of amyloid, providing a comprehensive assessment of the disease's presence and distribution.1451112

What is the purpose of this trial?

This study will investigate 99mTc-p5+14, an amyloid-reactive synthetic peptide, p5+14, radiolabeled with technetium-99m, as a radiotracer for detecting paamyloid deposits in patients with AL or ATTR-associated systemic amyloidosis, notably with cardiac involvement.

Research Team

JS

Jonathan S Wall, PhD

Principal Investigator

University of Tennessee Graduate School of Medicine

Eligibility Criteria

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.

Inclusion Criteria

I agree to use birth control if there's any chance of pregnancy with my partner.
I am a woman who can have children and have a recent negative pregnancy test.
I have been diagnosed with AL or ATTR amyloidosis.
See 5 more

Exclusion Criteria

I have taken heparin or similar drugs in the last week.
You are allergic to potassium iodide.
Your blood tests showed high levels of AST and bilirubin in the past six months.
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single IV dose of 99mTc-p5+14 and undergo imaging to evaluate dosimetry and biodistribution

8 days
Multiple imaging sessions including planar and SPECT/CT

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

  • 99mTc-p5+14
Trial Overview 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Tennessee Graduate School of Medicine

Lead Sponsor

Trials
17
Recruited
1,400+

Attralus, Inc.

Industry Sponsor

Trials
8
Recruited
670+

Findings from Research

The first-in-human study of the iodine-124 labeled peptide 124I-p5+14 demonstrated that it is well tolerated and rapidly accumulates in organs commonly affected by amyloidosis, such as the heart, kidneys, and liver, indicating its potential for effective imaging of amyloid deposits.
Dosimetry estimates for 124I-p5+14 were found to be acceptable for whole-body PET/CT imaging, with a low effective radiation dose of 0.23 mSv/MBq, suggesting that this imaging technique could be a safe and non-invasive method for diagnosing systemic AL amyloidosis.
First in Human Evaluation and Dosimetry Calculations for Peptide 124I-p5+14-a Novel Radiotracer for the Detection of Systemic Amyloidosis Using PET/CT Imaging.Wall, JS., Martin, EB., Endsley, A., et al.[2022]
A study involving 233 patients with suspected transthyretin cardiac amyloidosis demonstrated that a 1-hour imaging protocol using technetium-99 m pyrophosphate is as effective as the traditional 3-hour protocol for diagnosing the condition.
The 1-hour planar imaging showed high sensitivity (98%) and specificity (96%), indicating it can reliably identify patients with diffuse myocardial uptake, making it a more efficient option for diagnosis.
Efficient 1-Hour Technetium-99 m Pyrophosphate Imaging Protocol for the Diagnosis of Transthyretin Cardiac Amyloidosis.Masri, A., Bukhari, S., Ahmad, S., et al.[2021]
123I-labeled SAP scintigraphy demonstrated high diagnostic sensitivity for systemic AA and AL amyloidosis (90% each) and good specificity (93%), making it a reliable tool for identifying these types of amyloidosis in patients.
The technique revealed more extensive organ involvement than what was clinically detected, particularly showing frequent splenic amyloid deposits in AA and AL types, which were often missed in clinical evaluations.
Diagnostic performance of 123I-labeled serum amyloid P component scintigraphy in patients with amyloidosis.Hazenberg, BP., van Rijswijk, MH., Piers, DA., et al.[2022]

References

First in Human Evaluation and Dosimetry Calculations for Peptide 124I-p5+14-a Novel Radiotracer for the Detection of Systemic Amyloidosis Using PET/CT Imaging. [2022]
Efficient 1-Hour Technetium-99 m Pyrophosphate Imaging Protocol for the Diagnosis of Transthyretin Cardiac Amyloidosis. [2021]
Diagnostic performance of 123I-labeled serum amyloid P component scintigraphy in patients with amyloidosis. [2022]
Soft-tissue uptake of 99mTc-diphosphonate and 99mTc-pyrophosphate in amyloidosis. [2019]
Tc-99m Radiolabeled Peptide p5 + 14 is an Effective Probe for SPECT Imaging of Systemic Amyloidosis. [2019]
[Prospective survey on adverse effects of radiopharmaceuticals]. [2015]
Pediatric myelography with metrizamide. [2015]
Adverse reactions to radiopharmaceuticals. United Kingdom 1977-1983. [2016]
Evaluation of Radiopharmaceutical Adverse Reaction Reports to the British Nuclear Medicine Society from 2007 to 2016. [2018]
Adverse reactions and drug interactions with radiopharmaceuticals. [2018]
Clinical Confirmation of Pan-Amyloid Reactivity of Radioiodinated Peptide 124I-p5+14 (AT-01) in Patients with Diverse Types of Systemic Amyloidosis Demonstrated by PET/CT Imaging. [2023]
Dual-Energy SPECT and the Development of Peptide p5+14 for Imaging Amyloidosis. [2020]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security