Systemic AmyloidosisPhase 1NCT05951816
A Phase 1 Study of 99mTc-p5+14 in Healthy Volunteers and Patients With AL or ATTR Systemic Amyloidosis
A Phase 1 study testing 99mTc-p5+14 is an amyloid reactive peptide labeled with technetium-99m. and 99mTc-Pyrophosphate in people with Systemic Amyloidosis, run by University of Tennessee Graduate School of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Systemic Amyloidosis
- What is being tested?
- 99mTc-p5+14 is an amyloid reactive peptide labeled with technetium-99m. and 99mTc-Pyrophosphate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2023to Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PART 1
- 1) Understand the study procedures and agree to participate in the study by giving written informed consent..
- 2) 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.
- 4) 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.
- 5) 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.
- 6) Healthy volunteers must also meet inclusion criteria for Part 3. PART 2
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Tennessee Graduate School of Medicine
Knoxville, Tennessee, 37920
Emily B Martin, PhD, 865-305-9533, emartin@utmck.edu
Jonathan S Wall, PhD
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Systemic Amyloidosis
- Being tested
- 99mTc-p5+14 is an amyloid reactive peptide labeled with technetium-99m., 99mTc-Pyrophosphate
- Keywords
- Amyloidosis, p5+14, SPECT imaging, iodine-124-evuzamitide
- Medical subject headings
- Immunoglobulin Light-chain Amyloidosis, Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
99mTc-p5+14 is an amyloid reactive peptide labeled with technetium-99m.Drug
Peptide p5+14 is a pan-amyloid reactive, synthetic 45 L-amino acid polypeptide with a net +12 positive charge that can bind two major components of all extracellular amyloid deposits: (i) hypersulfated heparan sulfate glycosaminoglycans (proteoglycans) and (ii) amyloid fibrils. The polypeptide, labeled with iodine-124, has been shown (study AMY1001) to bind amyloid in all organs including the heart. This study will evaluate a Tc-99m-labeled version of the peptide for gamma imaging.
99mTc-PyrophosphateDrug
Also called 99mTc-PYP
99mTc-PYP is an FDA-approved, commercially available bone-seeking radiotracer used routinely in nuclear medicine. 99mTC-PYP imaging is used clinically for the diagnosis of cardiac ATTR amyloidosis.
| Study group | Role | What they receive |
|---|---|---|
| Estimation of dosimetry for 99mTc-p5+14 and Biodistribution Of 99mtc-p5+14 In Healthy Subjects | Experimental | For dosimetry, healthy subjects (n=3) and patients with a confirmed diagnosis of AL (n=1) or ATTR amyloidosis (n=1) 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.). Subjects 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 subject 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. An echo examination will also be performed.
For physiological biodistribution, healthy volunteers (n=5) will undergo an echo examination, thereafter, they will be administered a single IV dose of 99mTc-p5+14 (20 mCi) and will undergo a planar image acquisition followed by SPECT/CT imaging at ~1 hour and ~3 hours post-injection. Receives: Drug: 99mTc-p5+14 is an amyloid reactive peptide labeled with technetium-99m. |
| Biodistribution in patients with systemic AL or ATTR amlyoidosis | Experimental | On Day 1, 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 whole body planar imaging followed by abdominothoracic SPECT/CT imaging. 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. ECG measurements will be made within 1 hour prior to, and within 15 minutes after, 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 99mTc-PYP, and at ~3 hours post injection. ECG measurements will be made as on Day 1. Receives: Drug: 99mTc-p5+14 is an amyloid reactive peptide labeled with technetium-99m.; Drug: 99mTc-Pyrophosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole body effective dosimetry measurement
Whole body effective radiation dose assessed from analysis of organ-specific radioactivity uptake in planar and SPECT images.
Measured: From enrollment to the end of study is 8 days
Secondary outcomes (2)
Measure cardiac uptake of 99mTc-p5+14 radioactivity from planar and SPECT/CT images in comparison to 99mTc-PYP uptake
Measurement of 99mTc-p5+14 uptake in the heart of healthy volunteers and patients with systemic AL or ATTR amyloidosis and comparison with contemporaneous 99mTc-PYP cardiac radioactivity.
Measured: From enrollment to the end of study is 8 days
Measure uptake of 99mTc-p5+14 radioactivity in extracardiac tissues from planar and SPECT/CT images
Measurement of 99mTc-p5+14 radioactivity in abdominothoracic organs of healthy volunteers and patients with systemic AL or ATTR amyloidosis from planar and SPECT/CT images.
Measured: From enrollment to the end of study is 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start18 Sep 2023
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic AmyloidosisStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee Graduate School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Jonathan S Wall, PhD, Principal investigator, University of Tennessee Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951816
- Sponsor's protocol ID
- UTGSM-164388-101
- Status last verified
- Jul 2026
- First submitted
- 30 Jun 2023
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05951816
- Acronym / sponsor ID
- UTGSM-164388-101
- Conditions
- Systemic Amyloidosis
- Keywords
- Amyloidosis, p5+14, SPECT imaging, iodine-124-evuzamitide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- University of Tennessee Graduate School of MedicineUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 19 Jul 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 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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Estimation of dosimetry for 99mTc-p5+14 and Biodistribution Of 99mtc-p5+14 In Healthy Subjects | Experimental | Drug: 99mTc-p5+14 is an amyloid reactive peptide labeled with technetium-99m.For dosimetry, healthy subjects (n=3) and patients with a confirmed diagnosis of AL (n=1) or ATTR amyloidosis (n=1) 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.). Subjects 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 subject 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. An echo examination will also be performed. For physiological biodistribution, healthy volunteers (n=5) will undergo an echo examination, thereafter, they will be administered a single IV dose of 99mTc-p5+14 (20 mCi) and will undergo a planar image acquisition followed by SPECT/CT imaging at ~1 hour and ~3 hours post-injection. |
| Biodistribution in patients with systemic AL or ATTR amlyoidosis | Experimental | Drug: 99mTc-p5+14 is an amyloid reactive peptide labeled with technetium-99m., Drug: 99mTc-PyrophosphateOn Day 1, 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 whole body planar imaging followed by abdominothoracic SPECT/CT imaging. 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. ECG measurements will be made within 1 hour prior to, and within 15 minutes after, 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 99mTc-PYP, and at ~3 hours post injection. ECG measurements will be made as on Day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- PART 1
- 1) Understand the study procedures and agree to participate in the study by giving written informed consent..
- 2) 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.
- 4) 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.
- 5) 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 99mTc-p5+14 is an amyloid reactive peptide labeled with technetium-99m.Peptide p5+14 is a pan-amyloid reactive, synthetic 45 L-amino acid polypeptide with a net +12 positive charge that can bind two major components of all extracellular amyloid deposits: (i) hypersulfated heparan sulfate glycosaminoglycans (proteoglycans) and (ii) amyloid fibrils. The polypeptide, labeled with iodine-124, has been shown (study AMY1001) to bind amyloid in all organs including the heart. This study will evaluate a Tc-99m-labeled version of the peptide for gamma imaging. | Drug | Biodistribution in patients with systemic AL or ATTR amlyoidosis, Estimation of dosimetry for 99mTc-p5+14 and Biodistribution Of 99mtc-p5+14 In Healthy Subjects |
| 99mTc-PyrophosphateAlso: 99mTc-PYP99mTc-PYP is an FDA-approved, commercially available bone-seeking radiotracer used routinely in nuclear medicine. 99mTC-PYP imaging is used clinically for the diagnosis of cardiac ATTR amyloidosis. | Drug | Biodistribution in patients with systemic AL or ATTR amlyoidosis |
Primary outcome
Whole body effective dosimetry measurement
Time frame: From enrollment to the end of study is 8 days
Whole body effective radiation dose assessed from analysis of organ-specific radioactivity uptake in planar and SPECT images.
2 secondary outcomes
Measure cardiac uptake of 99mTc-p5+14 radioactivity from planar and SPECT/CT images in comparison to 99mTc-PYP uptake
Time frame: From enrollment to the end of study is 8 days
Measure uptake of 99mTc-p5+14 radioactivity in extracardiac tissues from planar and SPECT/CT images
Time frame: From enrollment to the end of study is 8 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Jonathan S Wall, PhD principal investigator
University of Tennessee Graduate School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 99mTc-p5+14 is an amyloid reactive peptide labeled with technetium-99m. and 99mTc-Pyrophosphate in people with Systemic Amyloidosis, run by University of Tennessee Graduate School of Medicine at 1 site in United States.
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 29 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emily B Martin, PhD (865-305-9533, emartin@utmck.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole body effective dosimetry measurement (time frame: From enrollment to the end of study is 8 days). 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 24 Jul 2026.