Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-02-27 @ 10:33 AM
Study NCT ID:
NCT03315351
Status:
COMPLETED
Last Update Posted:
2019-07-10
First Post:
2017-09-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Pet-scan at Day 1 of Brachytherapy for Patients With Cervical Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001918', 'term': 'Brachytherapy'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-09', 'studyFirstSubmitDate': '2017-09-25', 'studyFirstSubmitQcDate': '2017-10-16', 'lastUpdatePostDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of "TEP-Curie" (Brachytherapy driven by PET-scan) in terms of realized exams', 'timeFrame': '4 months', 'description': 'Concerning this outcome, the success in terms of feasibility will be the possibility of realizing the TEP-Curie exam'}, {'measure': 'Feasibility of "TEP-Curie" (Brachytherapy driven by PET-scan) regarding the possibility to define HR-CTV target volume (High-Risk Clinical Target Volume)', 'timeFrame': '4 months', 'description': 'Concerning this outcome, the success in terms of feasibility will be the possibility of defining a HR-CTV target volume for at least one of the 3 proposed approaches using the PET'}, {'measure': 'Feasibility of "TEP-Curie" (Brachytherapy driven by PET-scan) regarding the dicom medical image transfer', 'timeFrame': '4 months', 'description': 'Concerning this outcome, the success in terms of feasibility will be the possibility of transfering image in a Dicom format'}, {'measure': 'Feasibility of "TEP-Curie" (Brachytherapy driven by PET-scan) regarding the contouring possibility', 'timeFrame': '4 months', 'description': 'Using the possibility of defining the contouring for at least one of the 3 alternative treatment plans'}], 'secondaryOutcomes': [{'measure': 'Impact of the "TEP-Curie" (Brachytherapy driven by PET-scan) on target volume definition', 'timeFrame': '4 months', 'description': 'Comparison of the target volume obtained with TEP-curie to the target volume defined by the RMI alone'}, {'measure': 'Assessment of the HR-CTV coverage', 'timeFrame': '4 months', 'description': 'Comparison of the HR-CTV obtained with TEP-curie to the HR-CTV obtained by the RMI alone'}, {'measure': 'Assessment of the dose received by the neighboring target organs', 'timeFrame': '4 months', 'description': 'Comparison of the dose obtained with TEP-curie to the dose obtained by the RMI alone'}, {'measure': 'Time needed to design the different alternative treatment plans', 'timeFrame': '4 months'}, {'measure': 'Toxicity linked to the standard treatment driven by RMI only', 'timeFrame': '4 months', 'description': 'Graded according to the NCI CTCAE v4. scale'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PET-scan', 'Brachytherapy', 'Cervical Cancer'], 'conditions': ['Cervical Cancer']}, 'descriptionModule': {'briefSummary': 'Interventional, exploratory, prospective and monocentric study which aim to study the feasibility of brachytherapy using a PET-scan', 'detailedDescription': 'The study will proceed as follow:\n\n* Initial check-up before the brachytherapy, including a clinical exam, collect of disease history and other informations that can be required for a good execution of the trial, and a usual patient care (chemotherapy with concomitant radiotherapy, biopsy, RMI, PET-scan and paraaortic lymphadenectomy).\n* additional PET-scan exam at day 1 of the brachytherapy (with collect of informations on toxicity, clinical morphology data and biomorphological data of RMI and PET-scan, and dosimetric study of the brachytherapy)\n* 4 months after the brachytherapy, additional PET-scan monitoring metabolic volumes and standardized metabolic fixation parameters'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient suffering from a cervical cancer:\n* squamous-cell carcinoma or adenocarcinoma histologically proven\n* classified from FIGO 2009 IB2 to IVA stage\n* Age ≥ 18 years old\n* Examination by PET-scan and pelvic RMI realized at diagnosis\n* Examination by negative PET-scan remotely closed and at lymph node level\n* Surgical lymphadenectomy negative at paraaortic level\n* Treatment by external radiotherapy (doses between 45 Gy and 50.4 Gy in 1.8 Gy/fractions) and concomitant chemotherapy (at least 4 cures per weeks using platinum salt) done\n* Scheduled curative treatment by brachytherapy driven by RMI\n* Affiliation to the National Social Security System\n* With informed and signed consent before any procedure specific to the study\n\nExclusion Criteria:\n\n* Performance status of WHO score \\> 2\n* Other histology than squamous cell carcinoma or adenocarcinoma\n* Metastatic patient or paraaortic node positive\n* Adjuvant radiochemotherapy after the first surgery\n* Dementia or psychiatric history\n* Kidney failure\n* Diabet\n* Chronic inflammatory bowel disease\n* Pelvic and/or vesicoureteral surgery history\n* Pelvic irradiation history\n* Other active neoplasia or \\< 5 years old, except for basocellular carcinoma that can be locally treated\n* Contraindication to one of the following procedure : RMI, PET-scan, general anesthesia\n* Radiosensitive disease (Fragile X syndrome, Huntington's chorea, Xeroderma Pigmentosum, connective tissue disease) or signs of radiosensitivity.\n* Treatment with palliative intent\n* Pregnant or breastfeeding women\n* Patient Under guardianship or tutorship"}, 'identificationModule': {'nctId': 'NCT03315351', 'acronym': 'TEP-Curie', 'briefTitle': 'Feasibility of Pet-scan at Day 1 of Brachytherapy for Patients With Cervical Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Centre Oscar Lambret'}, 'officialTitle': 'Feasibility of PET-scan Carried Out at Day 1 of Brachytherapy for Patients With Locally Advanced Cervical Cancer Treated Initially by Concomitant Radio-chemotherapy', 'orgStudyIdInfo': {'id': 'TEP-Curie-1702'}, 'secondaryIdInfos': [{'id': '2017-A01888-45', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Procedure', 'description': 'Brachytherapy. PET-scan.', 'interventionNames': ['Procedure: Brachytherapy', 'Other: PET-scan']}], 'interventions': [{'name': 'Brachytherapy', 'type': 'PROCEDURE', 'description': "Before it starts, a consultation will be done to collect patient's informations and disease history, a clinical exam will be done and an evaluation of radio-chemotherapy toxicity will be realized.\n\nThe brachytherapy include a pulsating flow treatment driven by RMI and CT-scan", 'armGroupLabels': ['Study Procedure']}, {'name': 'PET-scan', 'type': 'OTHER', 'description': 'The patient will undergo 2 PET-scan during the clinical trial:\n\n* the first one is additional to the brachytherapy\n* the second one is realized 4 months after the brachytherapy', 'armGroupLabels': ['Study Procedure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59020', 'city': 'Lille', 'country': 'France', 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Abel CORDOBA, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre oscar Lambret de Lille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Oscar Lambret', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}