Study to see if new research scans can show how treatment affects the blood supply to kidney cancers

Phase 1

• Conditions: Primary and metastatic cancer. The active substance is a diagnostic agent that identifies angiogenesis associated with tumour growth.; MedDRA version: 14.1 Level: PT Classification code 10050018 Term: Renal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1 Level: PT Classification code 10038389 Term: Renal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-002833-20-GB
• Lead Sponsor: Oxford University Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-29
• Study Completion: 2015-11-03
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

A patient will be eligible for inclusion in this study if all of the following criteria apply:
1Patients should have advanced or metastatic RCC confirmed by histological diagnosis
2Patients considered suitable for therapy with TKI according to responsible clinician
3Measurable tumour according to RECIST v1.1 criteria
4Standard staging CT scan performed within 28 days of first research scan
5The patient has not received chemotherapy, radiotherapy, surgery or any other treatment against cancer within 4 weeks prior to recruitment
6Age =18 years
7Adequate renal function (creatinine <1.25xULN)
8Patient is able to tolerate and comply with scanning procedure
9Patient is not lactating or pregnant
10Patient is not known or suspected to have a hypersensitivity or allergy to Fluciclatide (18F) Injection or any of its components (including pABA).
11Absence of any psychological, familial, sociological or geographical condition which in the opinion of the Investigator may potentially hamper compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
12Able and willing to give informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 38

Exclusion Criteria

None

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified