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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002833-20 | EudraCT Number |
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| Name | Class |
|---|---|
| GE Healthcare | INDUSTRY |
| University of Oxford | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RCC Patients Antiangiogenic treatment | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-RGD-PET-CT and perfusion CT scans on 3 occasions | Drug | Fluciclatide (GE Healthcare) (AH111585) is a small cyclic peptide containing the RGD tripeptide (figure 1), which preferentially binds with high affinity to α¬vβ3 integrins that are up-regulated in angiogenesis. The IMP is supplied as a solution for injection, 400 MBq at the reference date and time. Participants will receive one injection of the imaging agent at this dose on 3 occasions |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in tumour uptake of the fluciclatide imaging agent | % change in SUVmax | Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Tumour response within an individual patient | % change in size | Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment |
| Changes of kinetic parameters on CT perfusion imaging |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fergus Gleeson | Oxford University Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiology, Oxford University Hospitals NHS Trust | Oxford | Oxfordshire | OX3 7LJ | United Kingdom |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C530281 | AH 111585 |
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BV, BF and Ki
| Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment |
| Absolute and relative tumour uptake and retention of fluciclatide | Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment |
| Progression free survival at 12 months- | Time from last study scan to the date of disease progression or death due to the disease,whichever occurs first. | 12 months after the final reseach scan. |
| Overall survival at 12 months | 12 months after the final reseach scan. |
| Safety profile | Number of participants with adverse events attributed to the 18F-RDG-PET imaging agent (CTCAE Criteria) | within 12 months of the last research scan |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |