Clinical trial · Interventional
Single Microdose Trial- CXCR4 PET Tracer - Pharmacokinetics and Pharmacodynamics of [68Ga]Ga-R54, a Radiopharmaceutical Directed Toward CXCR4 in Patients With Advanced Solid Neoplasia.
NCT07577206CI-TRIAL-00111048recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase 1, monocentric, open labeled, no profit "Microdose" trial. A single microdose of the new \[68Ga\]Ga-R54 PET radiopharmaceutical directed against CXCR4 will be injected into patients with advanced solid tumor or multiple myeloma to evaluate the binding.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [68Ga]Ga-R54 PET/CT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [68Ga]Ga-R54 PET/CT scan
- description
- Eligible patients with advanced or metastatic breast, pancreatic, colorectal, ovarian, lung cancer or multiple myeloma undergo screening with \[18F\]-FDG PET/CT and tumor CXCR4 immunohistochemical analysis on available cyto-histological material. Patients with CXCR4-positive tumors and confirmed eligibility are scheduled to undergo \[68Ga\]Ga-R54 PET/CT imaging within 8 days after a positive \[18F\]-FDG PET/CT scan. If immunohistochemical assessment is delayed beyond 8 days, a repeat \[18F\]-FDG PET/CT may be required to confirm eligibility before proceeding. The \[68Ga\]Ga-R54 PET/CT is performed according to protocol and does not interfere with planned therapeutic management. CXCR4-negative patients are considered screening failures and do not undergo investigational imaging.
- interventionNames
- Drug: [68Ga]Ga-R54 PET/CT
Primary outcomes (2)
- measure
- Quantitative analysis of the uptake (pharmacodynamics) of [68Ga]Ga-R54 in the neoplastic lesion by measuring the "maximum standardized uptake value" (SUVmax).
- timeFrame
- Single time point at PET/CT imaging (Day 1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients \> 18 years * Patients with histological diagnosis of solid neoplasm (breast, lung, colon, ovary, pancreas) in advanced stages or multiple myeloma evaluated by PET/CT with \[18F\]FDG carried out in the 3 months prior to enrollment. The neoplasm must express the CXCR4 receptor by immunohistochemistry * Patients with ECOG performance status 0-2, able to undergo the scheduled diagnostic procedure (PET/CT with \[68Ga\]Ga-R54). * Patients with alkaline phosphatase (AP), alanine aminotransferase (ALT), and aspartate aminotransferase \<3 x upper limit of reference range and total bilirubin \<2.0 mg/dL * Patients with creatinine \< 1.5 x upper limit of reference range or 24-hour creatinine clearance \> 50 mL/min * Negative serum pregnancy test (b-hCG) for women of childbearing age before administration of \[68Ga\]Ga-R54). * Signature of informed consent indicating that the patient (or legal representative) has been informed of all aspects pertinent to the study * Willingness and ability to comply with scheduled visits, laboratory tests and other study procedures. Exclusion Criteria: * Presence of active infections (e.g. requiring antibiotic therapy) or other serious concomitant illness, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study * Declared chronic active hepatitis (hepatitis B / C) * Declared active autoimmune diseases * Recovery from major trauma including surgery within 4 weeks of study enrollment * Presence of neurodegenerative diseases * Pregnancy and/or breastfeeding * Any conditions that in the opinion of the investigator could hinder compliance with the study protocol * Patients who have not signed consent to participate in the study
References
Publications (0)
Data not yet available
No reference posted for this study.