Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2026-01-01 @ 8:03 AM
Study NCT ID:
NCT01769950
Status:
UNKNOWN
Last Update Posted:
2013-01-17
First Post:
2013-01-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Choline-PET for Evaluating the Incidence of Nodal Metastases Among Newly Diagnosed Patients of Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-01-15', 'studyFirstSubmitDate': '2013-01-10', 'studyFirstSubmitQcDate': '2013-01-15', 'lastUpdatePostDateStruct': {'date': '2013-01-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Detection of extra-pelvic non-nodal metastases', 'timeFrame': 'Eligible participants will undergo a Choline-PET scan before the initiation of any cancer specific treatments, that is within a time frame of one week from the time of diagnosis', 'description': 'Evidence of extra-pelvic non-nodal metastases detected by Choline-PET scan will be recorded.'}], 'primaryOutcomes': [{'measure': 'Detection of Choline-PET detected nodal metastases', 'timeFrame': 'Eligible participants will undergo a Choline-PET scan before the initiation of any cancer specific treatments, that is within a time frame of one week from the time of diagnosis', 'description': 'At the time of diagnosis of prostate cancer, the investigators intend to utilize Choline-PET scan to gain evidence of nodal metastatic disease with a motive to assess for a potentially higher sensitivity than with the use of conventional imaging methods such as CT or MRI.'}], 'secondaryOutcomes': [{'measure': 'Comparison of Choline-PET and CT for the detection of nodal metastatic disease', 'timeFrame': 'Eligible participants will undergo a Choline-PET scan before the initiation of any cancer specific treatments, that is within a time frame of one week from the time of diagnosis', 'description': 'For each enrolled patient, the information regarding nodal metastatic disease gained from Choline-PET scan will be compared with CT scan data.'}, {'measure': 'Comparison of Choline-PET and MRI for the detection of nodal metastatic disease', 'timeFrame': 'Eligible participants will undergo a Choline-PET scan before the initiation of any cancer specific treatments, that is within a time frame of one week from the time of diagnosis', 'description': 'For each enrolled patient, the information regarding nodal metastatic disease gained from Choline-PET scan will be compared with MRI scan data.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Choline PET', 'Choline PET-CT', 'Positron emission tomography', 'Prostate cancer'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'Nodal involvement among patients with prostate cancer is known to be a poor prognostic factor. Traditionally, the presence or absence of nodal disease in patients with prostate cancer is ascertained with the use of anatomical imaging methods such as computed tomography (CT) and magnetic resonance imaging (MRI).\n\nHowever, the sensitivities of CT and MRI for the detection of pelvic nodal disease is rather low, with reports placing the value to lie between 50-80%.\n\nPositron emission tomography (PET) with the use of carbon-11 or fluorine-18 tagged choline (Choline-PET) is an approach which is known to deliver a high sensitivity for the imaging of prostate cancer disease burden in the primary, nodal and the metastatic areas.\n\nThe investigators in this prospective trial intend to utilize Choline-PET among all newly diagnosed patients of prostate cancer who are presumed to be non-N1 (absence of nodal disease on conventional imaging) and non-M1 (absence of metastatic disease on conventional imaging).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consenting patients\n* Diagnosed prostate cancer\n\nExclusion Criteria:\n\n* Metastatic disease at presentation'}, 'identificationModule': {'nctId': 'NCT01769950', 'acronym': 'ChoPEN', 'briefTitle': 'Choline-PET for Evaluating the Incidence of Nodal Metastases Among Newly Diagnosed Patients of Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Bangalore Institute of Oncology'}, 'officialTitle': 'Evaluation of the Incidence of Choline-PET Detected Nodal Metastases Among Newly Diagnosed Prostate Cancer Patients With Presumed Absence of Nodal and Distant Metastases.', 'orgStudyIdInfo': {'id': 'Choline-Prostate-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Choline-PET arm', 'description': 'Every eligible patient will be scanned with Choline-PET at the time of diagnosis of prostate cancer. MRI will also be obtained as it is the current standard of care. CT scan will be obtained as part of the same procedure while procuring the Choline-PET scan with PET-CT dual imaging hardware.', 'interventionNames': ['Other: Choline-PET']}], 'interventions': [{'name': 'Choline-PET', 'type': 'OTHER', 'otherNames': ['Choline PET-CT', 'Choline PET/CT', 'Carbon-11 Choline PET', 'Fluorine-18 Choline PET'], 'description': 'Carbon-11 or Fluorine-18 PET-CT will be acquired with a scanner with integrated PET and CT scanning ability at the time of diagnosis. It must be however noted that Choline-PET will not be considered as an alternative to magnetic resonance imaging (MRI). In fact, all patients will undergo MRI too.', 'armGroupLabels': ['Choline-PET arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '560027', 'city': 'Bengaluru', 'state': 'Karnataka', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Swaroop Revannasiddaiah, MD', 'role': 'CONTACT', 'email': 'swarooptheone@gmail.com', 'phone': '8971862565', 'phoneExt': '91'}, {'name': 'Sridhar P Susheela, MD', 'role': 'CONTACT', 'email': 'sridhar1973@ymail.com', 'phone': '9008482284', 'phoneExt': '91'}], 'facility': 'HealthCare Global- Bangalore Institute of Oncology', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}], 'centralContacts': [{'name': 'Sridhar P Susheela, MD, DNB', 'role': 'CONTACT', 'email': 'sridhar1973@ymail.com', 'phone': '9008482284', 'phoneExt': '91'}, {'name': 'Swaroop Revannasiddaiah, MD', 'role': 'CONTACT', 'email': 'swarooptheone@gmail.com', 'phone': '8971862565', 'phoneExt': '91'}], 'overallOfficials': [{'name': 'Ajaikumar Basavalingaiah, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'HealthCare Global- Bangalore Insititute of Oncology'}, {'name': 'Kumar G Kallur, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'HealthCare Global- Bangalore Institute of Oncology'}, {'name': 'Swaroop Revannasiddaiah, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'HealthCare Global- Bangalore Institute of Oncology'}, {'name': 'Sandeep Muzumder, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'HealthCare Global- Bangalore Institute of Oncology'}, {'name': 'Govindarajan Mallarajapatna, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'HealthCare Global- Bangalore Institute of Oncology'}, {'name': 'Raghunath S Krishnappa, MS, DNB', 'role': 'STUDY_DIRECTOR', 'affiliation': 'HealthCare Global- Bangalore Institute of Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bangalore Institute of Oncology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sridhar P Susheela', 'investigatorAffiliation': 'Bangalore Institute of Oncology'}}}}