NCT06557590

Brief Summary

To evaluate the potential usefulness of 18F-FAPI-04 positron emission tomography/computed tomography (PET/CT) and positron emission tomography/magnetic resonance imaging （PET/MR）for the diagnosis of primary and metastatic lesions, detection of recurrence or assessment of pathologic response in various types of cancer.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Jan 2024

Longer than P75 for all trials

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 Progress47%
Jan 2024Dec 2028

Study Start

First participant enrolled

January 1, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2024

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

August 16, 2024

Status Verified

August 1, 2024

Enrollment Period

5 years

First QC Date

August 14, 2024

Last Update Submit

August 14, 2024

Conditions

CancerFAP

Outcome Measures

Primary Outcomes (1)

  • Diagnostic Performance

    Diagnostic accuracy, The sensitivity, specificity and accuracy of 18F-FAPI-04 PET/CT and PET/MR were calculated.

    1 year

Interventions

18F-FAPI-04DIAGNOSTIC_TEST

18F-FAPI-04 was injected into the patients before the PET/CT or PET/MR scans

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with suspected or new diagnosed or previously treated malignant tumors.

You may qualify if:

  • patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

You may not qualify if:

  • patients with non-malignant lesions; patients with pregnancy; the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hunan Cancer hospital

Changsha, Hunan, 410000, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Hui Ye, PhD

CONTACT

13755117105yehui@hnca.org.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 14, 2024

First Posted

August 16, 2024

Study Start

January 1, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

August 16, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)