Clinical trial · Interventional
PET/CT Imaging of GRPR Expression in Various Tumors
NCT07828678CI-TRIAL-00126446not yet recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260919-000001
Summary
Brief summary (as posted)
This open-label imaging study will evaluate \[⁶⁸Ga\]-LY4257529 PET/CT, a gastrin-releasing peptide receptor (GRPR)-targeted radiopharmaceutical, in patients with cancers known or suspected to express GRPR. Up to 60 participants will be enrolled in two cohorts: 30 patients with breast cancer and 30 patients with other selected malignancies, including prostate, ovarian, pancreatic, small-cell lung, head and neck squamous cell carcinoma, and other tumors with documented GRPR expression.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignancies Multiple | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GRPR PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [⁶⁸Ga]-GRPR PET/CT
- description
- Participants with breast cancer or other selected GRPR-expressing malignancies will receive a single intravenous administration of approximately 170 MBq ±20% of \[⁶⁸Ga\]-LY4257529, followed by PET/CT imaging approximately 50-70 minutes after injection. All participants undergo the same imaging intervention.
- interventionNames
- Diagnostic Test: GRPR PET/CT
Primary outcomes (1)
- measure
- Per-Patient GRPR PET/CT Detection Rate
- timeFrame
- After the PET/CT imaging is completed
- description
- Proportion of participants with at least one GRPR-positive lesion on \[⁶⁸Ga\]-LY4257529 PET/CT. Detection rate will be calculated as the number of participants with at least one GRPR-positive lesion divided by the total number of participants in the relevant cancer cohort.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Age 18 years or older Able to understand and provide written informed consent Diagnosis of a breast cancer or other tumor known or suspected to express GRPR, including: ER-positive/HER2-negative breast cancer Invasive lobular breast cancer Head and neck squamous cell carcinoma Small-cell lung cancer Ovarian cancer Prostate cancer with biochemical recurrence and a negative PSMA PET/CT Metastatic pancreatic cancer after pancreatic surgery Other tumor with GRPR expression demonstrated on histopathology ECOG performance status 0-3 Under the care of a referring physician Able to tolerate PET/CT imaging, including lying supine for up to 30 minutes with arms above the head and intravenous cannulation Exclusion Criteria: Tumor type known in the literature not to express GRPR, unless patient-specific tissue demonstrates GRPR expression Medically unstable condition, including acute cardiac or respiratory distress or hypotension Weight exceeding PET/CT table limit of 200 kg or inability to fit within the 70-cm PET/CT bore Unmanageable claustrophobia Known allergic or hypersensitivity reaction to a prior GRPR-targeting radioligand such as ⁶⁸Ga-RM2 or bombesin analogues Pregnancy Lactation For individuals of childbearing potential, inability to document a negative pregnancy test before tracer administration
References
Publications (0)
Data not yet available
No reference posted for this study.