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NCT06943313
Breast Cancer PET/CT Imaging With 68Ga-pAKTi
trial testing 68Ga-pAKTi PET/CT probe in Breast Cancers in 20 participants. Enrolling by invitation.
31 July 2026
Quick facts
| Lead sponsor | Fudan University |
|---|---|
| Status | ENROLLING BY INVITATION |
| Study type | OBSERVATIONAL |
| Enrollment | 20 |
| Start date | 21 April 2025 |
| Primary completion | 31 July 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- 68Ga-pAKTi PET/CT probe
Conditions studied
- Breast Cancers — all drugs for Breast Cancers →
- PIK3CA Mutation-Related Tumors — all drugs for PIK3CA Mutation-Related Tumors →
- PI3K Pathway Activated Tumors — all drugs for PI3K Pathway Activated Tumors →
- PET / CT — all drugs for PET / CT →
Sponsor
Fudan University
Who can join
18 and older, female only, with Breast Cancers or PIK3CA Mutation-Related Tumors. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06943313
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06943313 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fudan University
- Last refreshed: 24 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06943313.
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