Clinical trial · Interventional
Diagnostic Imaging for Clear Cell Renal Cell Carcinoma
"An Exploratory Study Regarding the Use of the Biomarker Dopamine Transporter (DAT) for Image Diagnosis of Clear Cell Renal Cell Carcinoma"
NCT03185182CI-TRIAL-00039173RCCSCANterminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to "early stopping rule" as defined in the study protocol
Summary
Brief summary (as posted)
The main objective is to study whether imaging detection of the biomarker DAT can be used to detect kidney tumors identified by computer tomography (CT), which are pathologically assesses as being of the clear cell subtype.
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 |
|---|---|---|---|
| Clear Cell Renal Cell Carcinoma | Clear Cell Renal Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ioflupane I123 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- experimental group
- description
- 185 megabecquerel (MBq) of Ioflupane I-123 (DaTSCAN) will be administered IV to patients with suspected renal cell carcinoma, at a single occasion and followed by SPECT-analysis 5h after injection.The images from the DaTSCAN investigation will be analyzed and anatomically compared to CT-scan from the same the patient. Any adverse effects during the study will be reported. This is a exploratory open single arm trial, including a small number of patients with suspected disseminated renal cell carcinoma.
- interventionNames
- Drug: Ioflupane I123
Primary outcomes (1)
- measure
- Number of Participants That Display Ioflupane-positivity in Tumors Detected Via CT-scan
- timeFrame
- Through study completion for each participant, an average of 3 months
- description
- The primary endpoint is to investigate if tumors detected with CT display Ioflupane positivity in patients with verified clear cell renal cell carcinoma (ccRCC). Ioflupane signal was considered positive when intensity was \>3 times background signal in anatomic position identified as a lesion by CT-scan
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * suspected kidney cancer diagnosis * suspected spread of the cancer * patient is scheduled for surgery alternatively biopsy of kidney tumor * patient is 18 years or older * the patient has given their consent to participate in the study * female patients of reproductive age displays negative pregnancy test Exclusion Criteria: * known or suspected allergy to Ioflupane or sodium acetate or acetic acid or ethanol * patient suffers from moderate to severe renal impairment and exhibits glomerular filtration rate (GFR) \<40 * patient is medicated for Parkinson's disease * patient is medicated with any of the following medications: amphetamine, benzatropine, buproprion, cocaine, mazindol, methylphenidate, phentermine, sertraline, levodopa, dexamphetamine, lisdexamphetamine, modafinil, moclobemid, venlafaxine * patient is pregnant * breastfeeding * patient suffers from mental inability unwillingness or language difficulties resulting in difficulty in understanding the meaning of taking part in the study
References
Publications (0)
Data not yet available
No reference posted for this study.