Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2025-12-28 @ 8:52 AM
Study NCT ID:
NCT01492192
Status:
TERMINATED
Last Update Posted:
2017-11-01
First Post:
2011-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RGD-PET-CT in Cancer Angiogenesis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C530281', 'term': 'AH 111585'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-30', 'studyFirstSubmitDate': '2011-12-12', 'studyFirstSubmitQcDate': '2011-12-12', 'lastUpdatePostDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in tumour uptake of the fluciclatide imaging agent', 'timeFrame': 'Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment', 'description': '% change in SUVmax'}], 'secondaryOutcomes': [{'measure': 'Tumour response within an individual patient', 'timeFrame': 'Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment', 'description': '% change in size'}, {'measure': 'Changes of kinetic parameters on CT perfusion imaging', 'timeFrame': 'Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment', 'description': 'BV, BF and Ki'}, {'measure': 'Absolute and relative tumour uptake and retention of fluciclatide', 'timeFrame': 'Prior to starting anti-angiogenic treatment, repeat after ~4 and 16 weeks of treatment'}, {'measure': 'Progression free survival at 12 months-', 'timeFrame': '12 months after the final reseach scan.', 'description': 'Time from last study scan to the date of disease progression or death due to the disease,whichever occurs first.'}, {'measure': 'Overall survival at 12 months', 'timeFrame': '12 months after the final reseach scan.'}, {'measure': 'Safety profile', 'timeFrame': 'within 12 months of the last research scan', 'description': 'Number of participants with adverse events attributed to the 18F-RDG-PET imaging agent (CTCAE Criteria)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Angiogenesis', 'PET-CT', 'Perfusion-CT'], 'conditions': ['Carcinoma, Renal Cell']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients should have advanced or metastatic RCC confirmed by histological diagnosis\n2. Patients considered suitable for therapy with TKI for RCC according to responsible clinician\n3. Measurable tumour according to RECIST v1.1 criteria\n4. Standard staging CT scan performed within 28 days of first research scan\n5. The patient has not received chemotherapy, radiotherapy, surgery or any other treatment against cancer within 4 weeks prior to recruitment\n6. Age ≥18 years\n7. Adequate renal function (creatinine \\<1.25xULN)\n8. Patient is able to tolerate and comply with scanning procedure\n9. Patient is not lactating or pregnant\n10. 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\n11. Able and willing to give informed consent\n\nExclusion Criteria:\n\n* Not applicable'}, 'identificationModule': {'nctId': 'NCT01492192', 'briefTitle': 'RGD-PET-CT in Cancer Angiogenesis', 'organization': {'class': 'OTHER', 'fullName': 'Oxford University Hospitals NHS Trust'}, 'officialTitle': 'Prospective Study of 18F-RGD PET-CT in Assessment of Response to Antiangiogenic Treatment in Patients With Cancer and Comparison With Perfusion CT', 'orgStudyIdInfo': {'id': 'EP-TSC-663'}, 'secondaryIdInfos': [{'id': '2011-002833-20', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RCC Patients Antiangiogenic treatment', 'interventionNames': ['Drug: 18F-RGD-PET-CT and perfusion CT scans on 3 occasions']}], 'interventions': [{'name': '18F-RGD-PET-CT and perfusion CT scans on 3 occasions', 'type': 'DRUG', 'otherNames': ['αvβ3 Integrin Imaging with Fluciclatide (AH111585)'], 'description': '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.\n\nThe 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', 'armGroupLabels': ['RCC Patients Antiangiogenic treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OX3 7LJ', 'city': 'Oxford', 'state': 'Oxfordshire', 'country': 'United Kingdom', 'facility': 'Department of Radiology, Oxford University Hospitals NHS Trust', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Fergus Gleeson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oxford University Hospitals NHS Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oxford University Hospitals NHS Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'GE Healthcare', 'class': 'INDUSTRY'}, {'name': 'University of Oxford', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Quality Manager', 'investigatorFullName': 'Linda Ward', 'investigatorAffiliation': 'Oxford University Hospitals NHS Trust'}}}}