Diagnostic Imaging for Clear Cell Renal Cell Carcinoma (RCCSCAN)

March 25, 2019 updated by: Region Skane

"An Exploratory Study Regarding the Use of the Biomarker Dopamine Transporter (DAT) for Image Diagnosis of Clear Cell Renal Cell Carcinoma"

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden, 221 85
        • Skåne University hospital SUS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: experimental group

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.
Drug: Ioflupane I123

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.

Other Names:
  • DaTSCAN

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants That Display Ioflupane-positivity in Tumors Detected Via CT-scan
Time Frame: 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
Through study completion for each participant, an average of 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants Diagnosed With Non-ccRCC That Display Ioflupane I123-negativity in Tumors Detected Via CT-scan
Time Frame: 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
Through study completion for each participant, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Region Skane

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Lund University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Peter Elfving, M.D. PhD, Region Skane

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 14, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 12, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 12, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 14, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 21, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RCCSCAN
  • 2016-005182-31 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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