NCT07400224

Brief Summary

This prospective, single-center study investigates the biodistribution, dosimetry, safety, diagnostic performance of Al18F-NOTA-FAPI PET imaging in patients with malignant tumor,cardiovascular or immune disease. And evaluates the potential of Al18F-NOTA-FAPI PET imaging in Clinical treatment strategy guidance.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for phase_1

Timeline
33mo left

Started May 2022

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress59%
May 2022Dec 2028

Study Start

First participant enrolled

May 10, 2022

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

February 10, 2026

Status Verified

January 1, 2026

Enrollment Period

5.6 years

First QC Date

February 3, 2026

Last Update Submit

February 3, 2026

Conditions

Hyperthyroidism, AutoimmuneCardiovascular AbnormalitiesMalignant Tumor

Outcome Measures

Primary Outcomes (2)

  • Safety of Al18F-NOTA-FAPI

    Adverse effects were recorded according to CTCAE (version 5.0) after radiotracer injection and PET scan.

    From radiotracer injection to 24 hours post-injection.

  • Diagnostic accuracy of Al18F-NOTA-FAPI PET/CT(PET/MRI) for cardiovascular or immune disease.

    SUVmax 、SUVmean and T2 value（MRI）of the heart and the eye muscles will be measured. Two nuclear medicine physicians will independently review the images, and a third physician will adjudicate in case of disagreement to reach a final diagnosis. Surgical pathology results or Long term follow up findings will serve as the reference standard to determine the sensitivity and specificity .

    Through study completion, 1-1.5 years .

Secondary Outcomes (2)

  • SUVmax of normal organs

    From study completion to 6 months after completion.

  • Absorbed dose of target organs

    From study completion to 6 months after completion

Study Arms (1)

Al18F-NOTA-FAPI PET/CT(PET/MRI)

EXPERIMENTAL

Evaluation of dosimetry, safety, diagnostic accuracy, and clinical treatment strategy guidance ability of Al18F-NOTA-FAPI PET/CT(or PET/MRI) in patients with malignant tumor,cardiovascular or immune disease.

Other: Al18F-NOTA-FAPI PET/CT(or PET/MRI)

Interventions

Al18F-NOTA-FAPI PET/CT(or PET/MRI)OTHER

Participants will receive an intravenous injection of Al18F-NOTA-FAPI, prepared on-site and measured by qualified personnel using a dose calibrator, with readings and time recorded. The radiopharmaceutical will be slowly administered through a three-way stopcock, followed by a flush with 5 mL of normal saline. The recommended dose is approximately 4.81 MBq/kg (0.13 mCi/kg) body weight, with variations depending on drug yield and clinical scheduling. PET/CT(or PET/MRI) imaging are planned 45-90 minutes after administration, with adjustments based on drug yield and equipment availability.

Al18F-NOTA-FAPI PET/CT(PET/MRI)

Eligibility Criteria

Age18 Years - 88 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a. Age 18 years old or above, gender not restricted. b. Have undergone a health check-up within the last 3 months (at least completed chest X-ray / chest CT and abdominal B-ultrasound and other examinations), and no major diseases were found.

You may not qualify if:

  • As this study involves certain radiation exposure, patients who have had frequent radiation exposure due to clinical needs (those who have undergone a CT or PET/CT examination once within 3 months or 1 month respectively) are not included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Graves DiseaseCardiovascular AbnormalitiesNeoplasms

Condition Hierarchy (Ancestors)

ExophthalmosOrbital DiseasesEye DiseasesGoiterThyroid DiseasesEndocrine System DiseasesHyperthyroidismAutoimmune DiseasesImmune System DiseasesCardiovascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Li Huo, MD

CONTACT

+86 18612672038huoli@pumch.cn

Xueqian Yang, MS

CONTACT

+86 18801349606yangxq202508@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2026

First Posted

February 10, 2026

Study Start

May 10, 2022

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

February 10, 2026

Record last verified: 2026-01

Locations

CN(1)