RGD-PET-CT in Cancer Angiogenesis

NHS Trust

Status and phase: Terminated; Phase 2

Conditions: Carcinoma, Renal Cell

Treatments: Drug: 18F-RGD-PET-CT and perfusion CT scans on 3 occasions

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01492192

2011-002833-20 (EudraCT Number)

EP-TSC-663

Details and patient eligibility

About

The goal of this clinical research study is to look at 2 new methods of scanning and see whether they can help researchers predict which tumours will respond to drugs that attack tumour blood supply.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients should have advanced or metastatic RCC confirmed by histological diagnosis
2. Patients considered suitable for therapy with TKI for RCC according to responsible clinician
3. Measurable tumour according to RECIST v1.1 criteria
4. Standard staging CT scan performed within 28 days of first research scan
5. The patient has not received chemotherapy, radiotherapy, surgery or any other treatment against cancer within 4 weeks prior to recruitment
6. Age ≥18 years
7. Adequate renal function (creatinine <1.25xULN)
8. Patient is able to tolerate and comply with scanning procedure
9. Patient is not lactating or pregnant
10. Absence 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
11. Able and willing to give informed consent

Exclusion criteria

• Not applicable

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

RCC Patients Antiangiogenic treatment

Experimental group

Treatment:

Drug: 18F-RGD-PET-CT and perfusion CT scans on 3 occasions