Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2026-02-09 @ 9:44 PM
Study NCT ID:
NCT00547612
Status:
COMPLETED
Last Update Posted:
2012-03-16
First Post:
2007-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Positron Emission Tomography Using [18F]-Labeled Substance P Antagonist Receptor Quantifier in Finding Disease in Patients With Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002851', 'term': 'Chromatography, High Pressure Liquid'}], 'ancestors': [{'id': 'D002853', 'term': 'Chromatography, Liquid'}, {'id': 'D002845', 'term': 'Chromatography'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'primaryPurpose': 'DIAGNOSTIC'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-14', 'studyFirstSubmitDate': '2007-10-19', 'studyFirstSubmitQcDate': '2007-10-19', 'lastUpdatePostDateStruct': {'date': '2012-03-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of tumors detected by [18F]-labeled substance P antagonist receptor quantifier positron emission tomography'}]}, 'conditionsModule': {'keywords': ['adenocarcinoma of the pancreas', 'stage I pancreatic cancer', 'stage II pancreatic cancer', 'stage III pancreatic cancer', 'stage IV pancreatic cancer', 'recurrent pancreatic cancer'], 'conditions': ['Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) using \\[18F\\]-labeled substance P antagonist receptor quantifier, may be effective in finding disease in patients with pancreatic cancer.\n\nPURPOSE: This phase I trial is studying how well a PET scan using \\[18F\\]-labeled substance P antagonist receptor quantifier works in finding disease in patients with pancreatic cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine whether \\[18F\\]-labeled substance P antagonist receptor quantifier positron emission tomography can identify pancreatic cancer evident on multiphase CT scan.\n\nOUTLINE: Patients undergo multiphase CT scan of the chest, abdomen, and pelvis. No more than 15 days later, patients receive \\[18F\\]-labeled substance P antagonist receptor quantifier IV and undergo positron emission tomography over 6 hours.\n\nBlood is collected periodically to measure the metabolism of the radiotracer by high performance liquid chromatography with radioactive detectors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed adenocarcinoma of the pancreas\n\n * Primary or metastatic disease\n* At least one site of measurable disease\n* Enrolled in an NCI protocol (either a treatment or screening protocol) such as NCI-05-C-0044 or NCI-05-C-0141\n\nPATIENT CHARACTERISTICS:\n\nInclusion criteria:\n\n* ECOG performance status 0-2\n* WBC ≥ 1,200/mm³\n* Creatinine \\< 2.0 mg/dL\n* Negative pregnancy test\n* Fertile patients must agree to use effective contraception\n* Not pregnant or nursing\n\nExclusion criteria:\n\n* Allergy to IV contrast\n* Claustrophobia that would preclude completion of a scan or unable to lie on one's back for positron emission tomography scan\n\nPRIOR CONCURRENT THERAPY:\n\nInclusion criteria:\n\n* More than 4 weeks since prior abdominal surgery\n\nExclusion criteria:\n\n* Prior participation in other research protocols within the past year such that a radiation exposure together with the present study would exceed the annual limits\n* Aprepitant within 72 hours of \\[18F\\]-labeled substance P antagonist receptor quantifier positron emission tomography"}, 'identificationModule': {'nctId': 'NCT00547612', 'briefTitle': 'Positron Emission Tomography Using [18F]-Labeled Substance P Antagonist Receptor Quantifier in Finding Disease in Patients With Pancreatic Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Pilot Trial of the NK1 Receptor Radio-Ligand [18F]SPA-RQ: Imaging Pancreatic Ductal Adenocarcinoma', 'orgStudyIdInfo': {'id': '070222'}, 'secondaryIdInfos': [{'id': '07-C-0222'}, {'id': 'CDR0000570181'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'high performance liquid chromatography', 'type': 'OTHER'}, {'name': 'pharmacological study', 'type': 'OTHER'}, {'name': '[18F]-labeled substance P antagonist receptor quantifier', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892-1182', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Richard E. Royal, MD, FACS', 'role': 'STUDY_CHAIR', 'affiliation': 'NCI - Surgery Branch'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institutes of Health Clinical Center (CC)', 'class': 'NIH'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}