Breast Cancer PET/CT Imaging With 68Ga-pAKTi

NCT06943313 · tracked via the Priya Life Science China tracker

Sponsor

Fudan University

Phase

Observational

Started

2025-04-21

Last updated

2025-04-24

Condition(s) studied

Breast CancersPIK3CA Mutation-Related TumorsPI3K Pathway Activated TumorsPET / CT

Investigational drug(s) / intervention(s)

68Ga-pAKTi PET/CT probe

68Ga-pAKTi PET/CT probe: 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.

Study 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.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Voluntarily signs the informed consent form. 2. Age ≥ 18 years. 3. Pathologically confirmed or highly suspected breast cancer based on conventional imaging. 4. Estimated life expectancy \> 3 months as determined by the physician. 5. Agrees to practice strict contraception for at least 28 days following the PET/CT examination. 6. Willing and able to comply with the study protocol. 7. Has not undergone surgical resection of the lesion. 8. 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. Exclusion Criteria: 1. Pregnant or breastfeeding women. 2. Unable to lie still on the PET/CT scanner bed during the examination or intolerant to PET imaging. 3. Participation in another interventional clinical trial within 1 month prior to screening. 4. Patients who are lost to follow-up. 5. Any other condition that, in the opinion of the investigator, may interfere with the study or make the subject unsuitable for participation.

Primary outcome measure(s)

Standard uptake value — From enrollment to the end of imaging at 2 weeks

Trial sites (1)

Facility	City	Region	Status
Fudan University Shanghai Cancer Center	Shanghai	China

More Fudan University trials in China

The Safety and Efficacy of Multimodal Thermal Therapy in the Treatment of Early-stage Invasive Breast Cancer Starting soon

Comparing the Efficacy of Sintilimab Plus Nab-POF Regimen, Sintilimab Plus XELOX Chemotherapy, and Lenvatinib, Sintilimab Plus XELOX Chemotherapy in the Treatment of HER2-negative, Metastatic Gastric Cancer Starting soon

an AI-Driven Four-Tier Invasion Depth Classification for Early Esophageal Cancer Active, not recruiting

Pucotenlimab Combined With Becotatug Vedotin in Advanced Cutaneous Squamous Cell Carcinoma Starting soon

CDK4/6 Inhibitors Combined With Standard Adjuvant Endocrine Therapy in High-Risk, HR+/HER2+ Early Breast Cancer Patients(CHESS) Recruiting

Other trials for the same condition

A Phase II Single-Arm Clinical Study to Explore the Efficacy and Safety of Hyperbaric Oxygen in the Neoadjuvant Treatment of Triple-Negative and HER2+ Breast Cancer Patients Starting soon

A Clinical Study to Explore the Efficacy and Safety of Hyperbaric Oxygen in the Neoadjuvant Treatment of Hormone Receptor Positive Breast Cancer Patients Starting soon

A Phase II Single-Arm Clinical Study to Explore the Efficacy and Safety of Hyperbaric Oxygen in the Neoadjuvant Treatment of Breast Cancer Patients Recruiting

DLL3-Targeted PET/CT in Neuroendocrine Carcinoma Recruiting

68Ga-grazytracer PET Assists in Diagnosing Pseudoprogression Following Immunotherapy in Lung Cancer. Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06943313 on ClinicalTrials.gov ↗ ← All trials in China