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Clear Cell Renal Cell Carcinoma

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Iodine

Cadexomer iodine

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.

185 MBq ioflupane I123 will be administered at one single occasion to the study subjects A one time dose of DaTSCAN is given via intravenous injection of 185 MBq Ioflupane (I123) .

The patient takes potassium iodine tablets prior to the DatSCAN injection to protect the thyroid gland. At the time of the DaTSCAN examination, the patient is injected intravenously at slow rate with 185MBq DaTSCAN solution.

Ioflupane I123

Peter Elfving, M.D. PhD

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.

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.

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"

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

Ioflupane I123 displays no positive signal in lesions identifies by CT in patients with tumors classified as non-clear cell renal cell carcinoma

Lund University

Region Skane

AE were reported consecutively for each patient while included in the trial. Incidents may be observed by a doctor / nurse or reported by the subjects themselves. The subjects were asked an open question "Have you had any health problems since taking potassium iodide?" at each relevant study visit (below).

* When injecting DaTSCAN (Ioflupan I123)
* Immediately after the SPECT investigation
* 2 days after the DaTSCAN examination (through telephone interview from research nurse)

185 megabecquerel (MBq) of Ioflupane I-123 will be administered IV to patients with suspected renal cell carcinoma, at a single occasion and followed by SPECT-analysis 5h after injection.

Ioflupane I123: 185 MBq ioflupane I133 will be administered at one single occasion to the study subjects

Experimental Group

Age, Categorical

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Sweden

Region of Enrollment

Pathological assessment of renal cell carcinoma (RCC) subtype was determined following surgical resection of the tumour. This occurs after DaTSCAN analysis.

Classified as ccRCC=clear cell renal cell carcinoma or non-ccRCC=all other subtypes of kidney cancer

RCC subtype

Only 5 out of 10 intended patients were recruited in the study due to "early stopping rule" as defined in the study protocol as: terminate study if 4 patients with, by pathologist verified, ccRCC all display negative ioflupane signal in all lesions.

Professor Håkan Axelson

185 megabecquerel (MBq) of Ioflupane I-123 will be administered IV to patients with suspected renal cell carcinoma, at a single occasion and followed by SPECT-analysis 5h after injection.

Ioflupane I123: 185 MBq ioflupane I123 will be administered at one single occasion to the study subjects

Number of Participants That Display Ioflupane-positivity in Tumors Detected Via CT-scan

Patients with non-ccRCC as verified by pathologist

Spots Global Cancer Trial Database for ioflupane i123