Breast CancersNCT06943313
Breast Cancer PET/CT Imaging With 68Ga-pAKTi
An observational study of Breast Cancers and PIK3CA Mutation-Related Tumors, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancers, PIK3CA Mutation-Related Tumors, PI3K Pathway Activated Tumors
- What is being tested?
- 68Ga-pAKTi PET/CT probe
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 21 Apr 2025to 31 Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer patients.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 68Ga-Labeled pAKTi Molecular Probe Combined With PET/CT for Breast Cancer Imaging
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.
- Being tested
- 68Ga-pAKTi PET/CT probe
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-pAKTi PET/CT probeDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard uptake value
Measured: From enrollment to the end of imaging at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start21 Apr 2025 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancersStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaoli Song, PhD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06943313
- Sponsor's protocol ID
- 2503317-27
- Status last verified
- Apr 2025
- First submitted
- 17 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No