ClinicalTrials.gov record NCT05951816

A Phase 1 Study of 99mTc-p5+14 in Healthy Volunteers and Patients With AL or ATTR Systemic Amyloidosis

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Phase 1 Study to Investigate the Dosimetry and Biodistribution of a Single Intravenous Administration of 99mTc-p5+14 Using SPECT/CT Imaging and Planar Gamma Scintigraphy in Healthy Volunteers and Patients With AL or ATTR Systemic Amyloidosis

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 1An early-stage study, usually small, mainly to check safety, side effects and how much of a treatment can be given. Whether it works is not the main question yet.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age18 years old and older
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase 1 diagnostic study evaluates a radiolabeled peptide, 99mTc-p5+14, as an imaging tracer for systemic amyloidosis (including AL and ATTR). Participants receive a single intravenous dose of 99mTc-p5+14 and undergo serial planar and SPECT/CT imaging to measure where the tracer goes and how much radiation the body receives. Patients with amyloidosis may also have a contemporaneous 99mTc-PYP scan for comparison.

What it is studying. The study is testing the biodistribution (where the tracer accumulates) and the dosimetry (the radiation dose to the body and organs) after a single IV injection of 99mTc-p5+14, and it will compare cardiac uptake with 99mTc-PYP imaging in patients.

What the researchers hope to learn. Determine whole-body and organ radiation doses from 99mTc-p5+14, map tracer uptake in the heart and other organs in healthy people and in AL or ATTR amyloidosis, and compare cardiac uptake to 99mTc-PYP imaging.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • 99mTc-p5+14 is an amyloid reactive peptide labeled with technetium-99m.
  • 99mTc-Pyrophosphate

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • PART 1
  • Understand the study procedures and agree to participate in the study by giving written informed consent..
  • Be male or female >18 years of age. 3) Women of child-bearing potential (WOCBP) (those who have not been surgically sterilized, are not postmenopausal [i.e., last menstrual period >2 years ago without pharmaceutical intervention], and women who are fertile) must have a negative pregnancy test prior within 24 h prior to infusion.
  • WOCBP who are not exclusively in same-sex relationships and male participants with female sexual partners who are WOCBP must agree to use adequate contraceptive methods, defined as use of a condom by the male partner combined with use of a highly effective method of contraception by the female partner, for at least 2.5 days after injection of 99mTc-p5+14.
  • Be a healthy volunteer (n=3) or have a confirmed diagnosis of systemic amyloidosis (n=2) based on either a histologic confirmation with a biopsy containing deposits of apple-green birefringent, Congophilic material with aberrant organ-specific biomarkers indicating amyloid involvement, physical examination, or imaging study.
  • Healthy volunteers must also meet inclusion criteria for Part 3. PART 2
  • Understand the study procedures and agree to participate in the study by giving written informed consent.
  • Be male or female >18 years of age.
  • WOCBP (those who have not been surgically sterilized, are not postmenopausal [i.e., last menstrual period >2 years ago without pharmaceutical intervention], and women who are fertile) must have a negative pregnancy test prior within 24 h prior to infusion.
  • WOCBP who are not exclusively in same-sex relationships and male participants with female sexual partners who are WOCBP must agree to use adequate contraceptive methods, defined as use of a condom by the male partner combined with use of a highly effective method of contraception by the female partner, for at least 2.5 days after injection of 99mTc-p5+14.
  • Have one of the following:
  • a confirmed diagnosis of systemic AL amyloidosis, based on either a histologic confirmation of a cardiac or extracardiac biopsy containing deposits of apple-green birefringent, Congophilic material AND imaging parameters (ECHO or CMR) indicative of cardiac involvement.
  • a confirmed diagnosis of systemic ATTR amyloidosis, based on either a histologic confirmation of a cardiac biopsy containing deposits of apple-green birefringent, Congophilic material or extracardiac biopsy and imaging parameters (ECHO or CMR or 99mTc-PYP) indicative of cardiac involvement, with no evidence of abnormal serum free light chains.
  • Have a diagnosis of cardiac amyloidosis within 4 years of screening, or longer if contemporaneous clinical data indicates the persistent presence of cardiac amyloidosis.
  • PART 3
  • Understand the study procedures and agree to participate in the study by giving written informed consent.
  • Be male or female >18 years of age.
  • WOCBP (those who have not been surgically sterilized, are not postmenopausal [i.e., last menstrual period >2 years ago without pharmaceutical intervention], and women who are fertile) must have a negative pregnancy test prior within 24 h prior to infusion.
  • WOCBP who are not exclusively in same-sex relationships and male participants with female sexual partners who are WOCBP must agree to use adequate contraceptive methods, defined as use of a condom by the male partner combined with use of a highly effective method of contraception by the female partner, for at least 2.5 days after injection of 99mTc-p5+14.
  • Be in good general health, as determined by no clinically significant findings (including Type 2 diabetes mellitus) in the opinion of the Investigator from review of the medical history.
  • Does not have a diagnosis of amyloidosis nor has a first- or second-degree relative (parent, sibling, child, aunt, uncle, niece, nephew) with confirmed or suspected familial amyloidosis.
  • PART 4
  • Understand the study procedures and agree to participate in the study by giving written informed consent.
  • Be male or female >18 years of age.
  • Women of child-bearing potential (those who have not been surgically sterilized, are not postmenopausal [i.e., last menstrual period >2 years ago without pharmaceutical intervention], and women who are fertile) must have a negative pregnancy test prior within 24 h prior to infusion.
  • WOCBP who are not exclusively in same-sex relationships and male participants with female sexual partners who are WOCBP must agree to use adequate contraceptive methods, defined as use of a condom by the male partner combined with use of a highly effective method of contraception by the female partner, for at least 2.5 days after injection of 99mTc-p5+14.
  • Has a confirmed diagnosis of systemic ATTR amyloidosis, based on either a histologic confirmation of a cardiac biopsy containing deposits of apple-green birefringent, Congophilic material or extracardiac biopsy and imaging parameters (ECHO or CMR), or abnormal serum biomarkers indicative of cardiac involvement, with no evidence of abnormal serum free light chains.
  • Has a diagnosis of cardiac amyloidosis within 4 years of screening, or longer if contemporaneous clinical data indicates the persistent presence of cardiac amyloidosis.
  • Has a negative 99mTc-PYP imaging study.

Exclusion criteria

  • PARTS 1-4
  • Due to annual dosimetry limitations, patients who have participated in another nuclear medicine amyloid imaging clinical trial protocol and received tracer injection in the last 6 months.
  • Is pregnant or breast-feeding.
  • Is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of psychosis.
  • Receiving hemodialysis or peritoneal dialysis.
  • Has severe claustrophobia or any medical condition that would prevent completion of the imaging protocol.
  • Has any illness that, in the opinion of the Investigator, might confound the results of the study or pose additional risk to the subject.
  • Has received heparin or heparin analogs (e.g., enoxaparin, dalteparin, fondaparinux) within seven (7) days prior to 99mTc-p5+14 administration.
  • Have previously received any dose of p5+14, in any form.
  • Have a serum AST >2x the upper limit of normal or 80 IU/L AND total bilirubin > 1.5x the upper limit of normal or 1.8 mg/dL within the previous six months of enrollment.
  • Have a serum ALT >2x the upper limit of normal or 64 IU/L AND total bilirubin > 1.5x the upper limit of normal or 1.8 mg/dL within the previous six months of enrollment.
  • Have a QTc interval, using Bazett's formula (QTcB) of >530 ms, measured within six months prior to enrollment, or assessed prior to injection.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

The University of Tennessee Graduate School of Medicine (UTGSM) is investigating 99mTc-p5+14, an amyloid-reactive synthetic peptide, p5+14, radiolabeled with technetium-99m, as a radiotracer for planar gamma scintigraphy (PGS), single photon emission computed tomography (SPECT) or SPECT with x-ray computed tomography (SPECT/CT) for the diagnosis of systemic amyloidosis, notably with cardiac involvement. Based on nonclinical data and clinical data of 124I-p5+14 from Study AMY1001, peptide p5+14 binds many types of human amyloid and is rapidly cleared from the central compartment. When radiolabeled with 99mTc, p5+14 may enable visualization of amyloid laden tissues and organs by SPECT/CT imaging or PGS. Thus, this study has been designed to evaluate the dosimetry and biodistribution of 99mTc-p5+14 in patients with systemic amyloidosis compared with the biodistribution in healthy volunteers.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants receive a single intravenous (IV) injection of 99mTc‑p5+14 (up to 1 mg, ~20 mCi) and undergo nuclear imaging to track where the tracer goes in the body. For dosimetry subjects there are serial whole-body planar scans at about 30 minutes, 1, 2, 4, 6 and 24 hours after injection with a SPECT/CT at about 4 hours; for physiological biodistribution healthy volunteers there are planar and SPECT/CT scans at about 1 and 3 hours post-injection. Patients with AL or ATTR amyloidosis have planar and abdominothoracic SPECT/CT imaging at about 1 and 3 hours on Day 1, a transthoracic echocardiogram (echo) on Day 3, and a separate 99mTc‑PYP planar and SPECT/CT imaging session on Day 4 with similar vital-sign and ECG checks. Small blood samples (~2–3 mL) are taken before injection and at each imaging session to measure whole-blood radioactivity, and vital signs and ECGs are collected around the injections as described in the protocol.

How the study is structured. This is an interventional Phase 1 diagnostic study. The registry lists randomized allocation and a single-group intervention model; the study is not masked. Participants receive a single IV administration of 99mTc-p5+14 and then undergo scheduled imaging (planar gamma scintigraphy and SPECT/CT) at specified times after injection. The record also describes blood samples to measure radioactivity, echocardiography, vital signs and ECGs, and—for patients—a separate 99mTc-PYP imaging session for comparison.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on AL amyloidosis

Clinical trials69 trials listed for AL amyloidosisEvery trial the registry lists for AL amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in AL amyloidosis researchLatest monthly update: September 2026. Includes: Daratumumab alone. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Sep 18, 2023
Primary completion
December 2026 (estimated)
Study completion
June 2027 (estimated)
Target enrollment
31 participants (estimated)
Last updated on registry
Jul 24, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
University of Tennessee Graduate School of Medicine
Collaborators
  • Bayer

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

  • University of Tennessee Graduate School of MedicineRecruiting

    Knoxville, Tennessee, 37920 · United States

Terms used on this page · explanations by MedicalUpdates.ai

written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
WOCBP
Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
biopsy
Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
biomarkers
Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
inclusion criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
ECHO
An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
free light chains
Small pieces of antibody protein made by plasma cells and measured in a blood test. In some conditions, such as AL amyloidosis, abnormal free light chains are the source of the disease.
upper limit of normal
The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
QTc
A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
computed tomography
An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this website; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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