Clinical trial · Interventional
[18F]Fluciclatide PET Imaging of Pazopanib Response
Evaluation of [18F]FluciclatidePositron Emission Tomography For the Prediction of Response to Pazopanib In Patients With Metastatic Renal Cell Carcinoma: An Exploratory Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Termination of \[18F\]Fluciclatide production
Summary
Brief summary (as posted)
Positron emission tomography (PET) is a non-invasive imaging tool for monitoring functional and metabolic responses of biological events with specific radiotracer in vivo. The PET tracer \[18F\]Fluciclatide is an 18F radiolabeled small peptide containing the RGD (arginine-glycine-aspartate) tri-peptide, which preferentially binds with high affinity to αvβ3 and αvβ5 integrins. αvβ3-integrins are expressed at low levels on epithelial cells and mature endothelial cells but are expressed at high levels on activated endothelial cells in the neo-vasculature of a range of tumors and it also may regulate angiogenesis. If pazopanib acts mainly on active angiogenetic tumors, the quantitative uptake of \[18F\]Fluciclatide can be used to predict the effect of this antiangiogenic drug. The investigators expected the baseline tumor uptake in \[18F\]Fluciclatide to be able to predict treatment response, and planned a study of \[18F\]FluciclatidePET for patients with metastatic RCC who received pazopanib systemic therapy.
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 |
|---|---|---|---|
| Kidney Neoplasm | Kidney Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-Fluciclatide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Drug; 18F-Fluciclatide
- description
- 18F-Fluciclatide, 0.14 mCi/kg (not to exceed 10 mCi), IV(in the vein) administration
- interventionNames
- Drug: 18F-Fluciclatide
Primary outcomes (1)
- measure
- Baseline 18F-Fluciclatide PET SUV
- timeFrame
- Prior to starting Pazopanib treatment
- description
- The difference of the baseline 18F-Fluciclatide PET SUV between responders and non-responders by RECIST criteria after Pazopanib therapy
Secondary outcomes (2)
- measure
- The difference of 18F-Fluciclatide PET parameters (% change of SUV) between responders and non-responders by RECIST criteria
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed renal cell carcinoma, stage IV patient. * The tumor mass ≥1.5cm in diameter that is planned to receive Pazopanib as systemic antiangiogenic therapy. * Pretreatment CT with or without contrast within 4 weeks prior to the first 18F-Fluciclatide PET scan. * Evidence of unidimensionally measurable lesion(s) by RECIST criteria version 1.1. * No prior systemic anti-angiogenic therapy for metastatic disease; prior antiangiogenic therapy used as an adjuvant therapy is allowed if it is completed 6 or more months before study enrollment. * Male or female aged over 20 years * Be ambulatory and have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * Have a life expectancy of at least 3 months. * Adequate medical condition in the judgment of the investigator * Be willing and able to comply with the protocol for the duration of the study. * Be willing and able to implement effective contraceptive practice * Give written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice. Exclusion Criteria: * Received another IMP within 30 days before the first administration of 18F-Fluciclatide injection. * Inability to perform 18F-Fluciclatide PET imaging studies due to physical inability or claustrophobia. * Intra-hepatic tumor only (without extra-hepatic tumor) * Chemotherapy within 2weeks, or received radiotherapy to the region of the target lesion, surgery of target lesion within 2 weeks prior to the first 18F-Fluciclatide PET scan * Pregnant, nursing women or patients with reproductive potential without contraception. * Current treatment on another therapeutic clinical trial(except Pazopanib study) * Any patients with known allergy to the GE health care product or any or its excipients should be excluded from the study * Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements.
References
Publications (0)
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