NCT05976620

Brief Summary

The goal of this observational study is to learn about the value of 18F-FAPI-RGD PET/CT imaging in Breast Tumors. Participants will undergo clinical evaluation and 18F-FAPI-RGD PET/CT examination.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 26, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 4, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2024

Completed
Last Updated

July 15, 2024

Status Verified

July 1, 2024

Enrollment Period

6 months

First QC Date

July 26, 2023

Last Update Submit

July 11, 2024

Conditions

Breast Tumors

Outcome Measures

Primary Outcomes (1)

  • Correlation between clinical indicators and PET/CT results

    Correlation of Immunohistochemical indexes, ultrasound, X-ray, CT, MRI, tumor markers，estrogen assay and 18F-FAPI-RGD PET/CT results

    2 months

Eligibility Criteria

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

Patients with diagnosed or highly suspected breast cancer

You may qualify if:

  • Age 18 and above
  • No gender difference
  • Patients who have been diagnosed with, or are clinically highly suspected of, breast tumors and have had no other treatment within 3 months
  • Tumor size (T), lymph node status (N), and overall clinical stage of diagnosed patients were determined according to the American Joint Committee on Cancer criteria revised in 2010

You may not qualify if:

  • Patients with a second primary tumor
  • Pregnant or breastfeeding
  • Severe liver or kidney disease
  • Claustrophobia or other PET/CT scan contraindications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departments of Nuclear Medicine, Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 26, 2023

First Posted

August 4, 2023

Study Start

June 20, 2023

Primary Completion

December 15, 2023

Study Completion

February 20, 2024

Last Updated

July 15, 2024

Record last verified: 2024-07

Locations

CN(1)