Diagnostic Imaging for Clear Cell Renal Cell Carcinoma

Phase 2

Terminated

Conditions: Clear Cell Renal Cell Carcinoma

Interventions: Drug: Ioflupane I123

Registration Number: NCT03185182

Lead Sponsor: Region Skane

Brief Summary: 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.

Detailed Description: Main objective of the trial:

The main objective is to investigate whether DaTSCAN with subsequent SPECT can detect elevated DAT levels in at least a lesion identified with CT in patients with clear cell renal cell carcinoma, as assesed by pathologist? DaTSCAN signal will be seen as positive, displaying intensity ≥3ggr higher than the background and correlating anatomically with at least one lesion found with CT. DaTSCAN is used routinely to detect the loss of dopaminergic neurons in the striatum of patients with clinically uncertain Parkinsonian Syndromes. The active substance in DaTSCAN, Ioflupane specifically binds to DAT. By analyzing the focal uptake of Ioflupane (123I) with SPECT / CT the progression of the disease may be clarified. In light of our findings that clear cell renal cancer express significantly elevated levels of DAT, we postulate that DaTSCAN can be used for detection of clear cell renal cell carcinoma.

Protection of trial subjects:

Very few adverse effects are reported for DatSCAN use. In this study we used the same dose and route of administration as is praxis for DaTSCAN when used for diagnostic investigation of Parkinsons disease. Albeit uncommon, pain at the injection site has been previously reported when the solution was injected into a small vain. To minimise the potential for pain at the injection site during administration in this study, a slow intravenous injection (not less than 15 to 20 seconds) via an arm vein was therefore applied. The injections were performed by routined staff at Skåne University Hospital, Department of Clinical Physiology / Nuclear Medicine in Malmö, where usual clinical preparedness for allergic reactions after injection was available.

Background therapy:

Patients underwent appropriate thyroid blocking treatment prior to injection of DaTSCAN, to minimise thyroid uptake of radioactive iodine. In this study, this was achieved by oral administration of 2x 65 mg potassium iodide tablettes on the night before the DaTSCAN investigation and another 2x 65 mg potassium iodine tabletts 1 hour prior to injection of DaTSCAN.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 5

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
experimental group	Ioflupane I123	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants That Display Ioflupane-positivity in Tumors Detected Via CT-scan	Through study completion for each participant, an average of 3 months	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

Secondary Outcome Measures

Name	Time	Method
Number of Participants Diagnosed With Non-ccRCC That Display Ioflupane I123-negativity in Tumors Detected Via CT-scan	Through study completion for each participant, an average of 3 months	Ioflupane I123 displays no positive signal in lesions identifies by CT in patients with tumors classified as non-clear cell renal cell carcinoma