[18F]FIDT-10b PET Imaging in Cardiac Amyloidosis

NCT07835880 | Not Yet Recruiting Phase 1

• 1 other identifier: FIDTCA
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This is a first in human study that will assess the safety, pharmacokinetics, biodistribution and diagnostic performance of \[18F\]FIDT-10b (fluorine-18 labeled FIDT-10b), a positron emission tomography (PET) agent. This agent has the potential to specifically identify the involved myocardium of patients with transthyretin cardiac amyloidosis (ATTR-CA).

Conditions

Transthyretin Cardiac Amyloidosis; Light Chain Cardiac Amyloidosis

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability evaluation (Part 1)

  The safety will be assessed by the number and percentage of patients with adverse events; Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.

  Within 30 days following PET imaging

• Focal or diffuse myocardial lesions of ATTR-CA identified with [18F]FIDT-10b PET imaging (Part 2)

  The reference standard comprised biopsy-proven extracardiac amyloidosis or pathogenic TTR mutation on genetic testing, in both cases accompanied by typical cardiac imaging appearance; a positive endomyocardial biopsy also served as an independent reference standard.

  Through study completion, an average of 3 months

Secondary Outcomes (5)

• Radiation Dosimetry of [18F]FIDT-10b

  Through study completion, an average of 3 months

• Biodistribution of [18F]FIDT-10b

  Through study completion, an average of 3 months

• Identify the ideal time point for imaging after [18F]FIDT-10b injection

  Through study completion, an average of 3 months

• Diagnostic performance of [18F]FIDT-10b for ATTR-CA

  Through study completion, an average of 3 months

• Preliminary assessment of lesion targeting by [18F]FIDT-10b as compared to 99mTc-PYP

  Through study completion, an average of 3 months

Study Arms (4)

Part 1-Dosimetry and Proof of Concept Study-Cohort A

EXPERIMENTAL

Healthy participants receive \[18F\]FIDT-10b for PET imaging.

Drug: [18F]FIDT-10b

Part 1-Dosimetry and Proof of Concept Study-Cohort B

EXPERIMENTAL

ATTR-CA participants receive \[18F\]FIDT-10b for PET imaging to see how the drugs work in the myocardium.

Drug: [18F]FIDT-10b; Drug: 99mTc-PYP

Part 1-Dosimetry and Proof of Concept Study-Cohort C

EXPERIMENTAL

AL-CA participants receive \[18F\]FIDT-10b for PET imaging to see how the drugs work in the myocardium.

Drug: [18F]FIDT-10b

Part 2-Diagnostic Performance Study

EXPERIMENTAL

Suspected or confirmed ATTR-CA participants receive \[18F\]FIDT-10b for PET imaging to explore the potential diagnostic performance and additional value of 99mTc-PYP scintigraphy.

Drug: [18F]FIDT-10b; Drug: 99mTc-PYP

Interventions

[18F]FIDT-10b DRUG

An I.V. bolus injection of up to 10 millicurie (mCi) \[18F\]FIDT-10b will be administered, followed by a PET/CT scan.

Part 1-Dosimetry and Proof of Concept Study-Cohort A

99mTc-PYP DRUG

An I.V. bolus injection of up to 30 millicurie (mCi) 99mTc-PYP will be administered, followed by a SPECT planar and SPECT/CT scan.

Part 1-Dosimetry and Proof of Concept Study-Cohort B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For part 1 and 2:
• must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements
• Only for part 1:
• For ATTR-CA participants:
• males or females: age 18-90 years
• with a confirmed diagnosis of ATTR-CA by standard criteria
• For AL-CA participants:
• males or females: age 18-80 years
• with a confirmed diagnosis of AL-CA by standard criteria
• For healthy participants:
• males or females: age 18-80 years
• no cardiac-related diseases
• Only for part 2:
• males or females: age 18-90 years
• suspected or confirmed ATTR-CA

You may not qualify if:

• For part 1 and 2:
• pregnancy or breastfeeding
• severe claustrophobia
• inability or refusal of consent
• any condition deemed by the investigator to interfere with study results or increase participant risk
• Only for part 1:
• For ATTR-CA participants:
• non-ischemic cardiomyopathy due to other causes of myocardial hypertrophy
• diagnosis of primary or secondary AL-CA
• contraindications for MRI (eGFR\<30ml/min/1.73m2; gadolinium allergy; metallic implants or device not suited for MRI)
• For AL-CA participants:
• co-diagnosis of multiple myeloma, Waldenström macroglobulinemia, or other lymphoproliferative disorders
• For healthy participants:
• any cardiac-related diseases based on medical history and corresponding clinical evaluations, including electrocardiography, echocardiography, and laboratory tests
• Only for part 2:

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

Location

MeSH Terms

Interventions

Technetium Tc 99m Pyrophosphate

Intervention Hierarchy (Ancestors)

Diphosphates; Polyphosphates; Phosphates; Phosphoric Acids; Phosphorus Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Phosphorus Compounds; Technetium Compounds

Central Study Contacts

Li Huo

CONTACT

+86 18612672038; huoli@pumch.cn

Xuezhu Wang

CONTACT

+86 19801117760; xuezhu1226@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 23, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 23, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within 2 years after the publication of the main results

Locations

CN (1)