[⁶⁸Ga]Ga-HKG301 PET/CT for staging and restaging patients with primary breast cancer: a phase II study (FAPILOUS)

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-521324-29-00

Enrollment

Registered

2026-08-14

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary breast cancer

Brief summary

Sensitivity, specificity, predictive values, and accuracy for primary staging and restaging breast cancer with [⁶⁸Ga]Ga-HKG301 PET/CT

Detailed description

The correlation between the response measures observed on [⁶⁸Ga]Ga-HKG301 PET/CT and the histopathological response, The influence of [⁶⁸Ga]Ga-HKG301 PET/CT on stage migration, alterations in treatment decisions, and incidental findings, Evaluate safety and tolerability of [⁶⁸Ga]Ga-HKG301

Interventions

DRUGAAA514

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Sensitivity, specificity, predictive values, and accuracy for primary staging and restaging breast cancer with [⁶⁸Ga]Ga-HKG301 PET/CT	—

Secondary

Measure	Time frame
The correlation between the response measures observed on [⁶⁸Ga]Ga-HKG301 PET/CT and the histopathological response, The influence of [⁶⁸Ga]Ga-HKG301 PET/CT on stage migration, alterations in treatment decisions, and incidental findings, Evaluate safety and tolerability of [⁶⁸Ga]Ga-HKG301	—

Outcome results

None listed

Source: EU CTIS · Data processed: Aug 15, 2026