Diagnostic Imaging for Clear Cell Renal Cell Carcinoma

NCT03185182 | Terminated Phase 2 Results

• 2 other identifiers: RCCSCAN2016-005182-31
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Clear Cell Renal Cell Carcinoma

Keywords

Diagnosis; Imaging

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (1)

• 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

Study Arms (1)

experimental group

EXPERIMENTAL

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

Interventions

Ioflupane I123 DRUG

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.

Also known as: DaTSCAN

experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Skane: lead
• Lund University: collaborator

Study Sites (1)

Skåne University hospital SUS

Lund, 221 85, Sweden

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Disease

Interventions

ioflupane

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

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.

Results Point of Contact

• Title: Professor Håkan Axelson
• Organization: Lund University

hakan.axelson@med.lu.se

+46 046 2226434

Study Officials

• Peter Elfving, M.D. PhD

  Region Skane

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: June 14, 2017
• Study Start: July 14, 2017
• Primary Completion: September 12, 2018
• Study Completion: September 12, 2018
• Last Updated: June 21, 2019
• Results First Posted: June 21, 2019

Record last verified: 2019-03

Locations

SE (1)