Breast Cancer PET/CT Imaging With 68Ga-pAKTi

NCT06943313 | Enrolling By Invitation DMC

• 1 other identifier: 2503317-27
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Abnormal activation of the PI3K-AKT signaling pathway in breast cancer patients is closely associated with tumor progression. Phosphorylated AKT (p-AKT) serves as a key indicator of pathway activation. In this study, we utilize a novel probe, 68Ga-pAKTi, which enables precise targeting of tumor p-AKT expression levels to monitor PI3K-AKT pathway activation. The aim of this study is to evaluate the diagnostic accuracy of 68Ga-pAKTi PET/CT in detecting p-AKT expression in breast cancer and to compare its performance with that of 18F-FDG PET/CT. A total of 20 patients with breast cancer will be enrolled. Screening will be conducted within 14 days prior to administration of 68Ga-pAKTi (from Day -14 to Day -1). Subjects who meet all inclusion criteria and none of the exclusion criteria will receive an intravenous injection of 68Ga-pAKTi on Day 0, followed by PET/CT imaging. Biopsy/pathological results and conventional imaging findings will be followed up to validate the diagnostic efficacy of 68Ga-pAKTi PET/CT in accurately detecting p-AKT expression in breast cancer.

Conditions

Breast Cancers; PIK3CA Mutation-Related Tumors; PI3K Pathway Activated Tumors; PET / CT

Outcome Measures

Primary Outcomes (1)

• Standard uptake value

  From enrollment to the end of imaging at 2 weeks

Interventions

68Ga-pAKTi PET/CT probe DIAGNOSTIC_TEST

A total of 20 patients with breast cancer will be enrolled. Screening will be conducted within 14 days prior to administration of 68Ga-pAKTi (from Day -14 to Day -1). Subjects who meet all inclusion criteria and none of the exclusion criteria will receive an intravenous injection of 68Ga-pAKTi on Day 0, followed by PET/CT imaging.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients.

You may qualify if:

• Voluntarily signs the informed consent form.
• Age ≥ 18 years.
• Pathologically confirmed or highly suspected breast cancer based on conventional imaging.
• Estimated life expectancy \> 3 months as determined by the physician.
• Agrees to practice strict contraception for at least 28 days following the PET/CT examination.
• Willing and able to comply with the study protocol.
• Has not undergone surgical resection of the lesion.
• Has participated in molecular testing at the Precision Oncology Center of Fudan University Shanghai Cancer Center, and harbors a PIK3CA mutation, PTEN mutation, or upregulation of the PI3K-AKT-mTOR pathway.

You may not qualify if:

• Pregnant or breastfeeding women.
• Unable to lie still on the PET/CT scanner bed during the examination or intolerant to PET imaging.
• Participation in another interventional clinical trial within 1 month prior to screening.
• Patients who are lost to follow-up.
• Any other condition that, in the opinion of the investigator, may interfere with the study or make the subject unsuitable for participation.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

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: April 17, 2025
• First Posted: April 24, 2025
• Study Start: April 21, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 24, 2025

Record last verified: 2025-04

Locations

CN (1)