Trial Outcomes & Findings for Diagnostic Imaging for Clear Cell Renal Cell Carcinoma (NCT NCT03185182)

Last Updated: 2019-06-21

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

Through study completion for each participant, an average of 3 months

Results posted on

2019-06-21

Participant Flow

Patients were recruited continously in this study. Five patients were recruited, all at the Urological Clinic at Skåne University Hospital, Jan Waldenströms gata 7, 205 02 Malmö, Sweden. The first patient was recruited 2017-07-14 and the last patient was recruited at 2018-05-23.

Patients were recruited continously in this study. Screening critera: suspected dissiminated renal cancer, age 18-70. Five patients were screened for the study and all five patients were considered suitable for enrollment.

Participant milestones

Participant milestones
Measure	Experimental Group 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
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental Group n=5 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	55 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment Sweden	5 participants n=5 Participants
RCC subtype ccRCC	4 Participants n=5 Participants
RCC subtype non-ccRCC	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Through study completion for each participant, an average of 3 months

Outcome measures

Outcome measures
Measure	Experimental Group n=5 Participants 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	0 Participants

SECONDARY outcome

Timeframe: Through study completion for each participant, an average of 3 months

Population: Patients with non-ccRCC as verified by pathologist

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

Outcome measures

Outcome measures
Measure	Experimental Group n=1 Participants 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 Diagnosed With Non-ccRCC That Display Ioflupane I123-negativity in Tumors Detected Via CT-scan	1 Participants

Adverse Events

Experimental Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Håkan Axelson

Lund University

Phone: +46 046 2226434

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place