- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02862288
Preliminary Study of Microwave Tumoral Ablation Performances for the Treatment of Pulmonary, Renal and Bone Neoplasia. (TherMO)
August 8, 2016 updated by: Centre Hospitalier Universitaire de Besancon
The aims of this work were to assess the feasibility, efficacy, short-term outcome and safety of microwave ablation in the treatment of malignant bone, lung and renal tumors.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Besançon, France, 25000
- CHU Besançon
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Men and women > 18 years old
- Thermoablation indication of renal neoplasia, bone or lung decided during a multidisciplinary consultation meeting - Generally speaking, the indications are: (i) inoperable primary malignant tumor or secondary malignant tumor, (ii) resectable primary malignant renal and lung tumor with medical contraindication to surgery or general anesthesia
- Signature of informed consent for participation
- Affiliation to a social security scheme or French beneficiary of such a regime.
Exclusion Criteria:
- Contraindication to percutaneous thermoablation
- Renal or lung tumor up to 4 cm
- Women of childbearing age, premenopausal, non-sterilized surgically, and unwilling to use effective contraception
- Legal incapacity or legal capacity limited
- Person unlikely to cooperate in the study and / or low degree of cooperation expected by the investigator
- Person without health insurance
- Pregnant women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Renal tumor
Microwave ablation of renal tumor
|
|
Experimental: Lung tumor
Microwave ablation of lung tumor
|
|
Experimental: Bone tumor
Microwave ablation of bone tumor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Tumor necrosis rate in post-intervention over one month monitoring period.
Time Frame: one month
|
one month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sébastien Aubry, M.D., Centre Hospitalier Régional Universitaire de Besançon
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Actual)
February 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
August 1, 2016
First Submitted That Met QC Criteria
August 8, 2016
First Posted (Estimate)
August 11, 2016
Study Record Updates
Last Update Posted (Estimate)
August 11, 2016
Last Update Submitted That Met QC Criteria
August 8, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- API/2011/23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Renal Tumor
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedClear Cell Renal Cell Carcinoma | Stage III Renal Cell Cancer | Stage IV Renal Cell Cancer | Clear Cell Sarcoma of the Kidney | Papillary Renal Cell Carcinoma | Rhabdoid Tumor of the Kidney | Stage I Renal Cell Cancer | Childhood Renal Cell Carcinoma | Stage II Renal Cell Cancer | Stage I Renal Wilms Tumor and other conditionsUnited States, Canada, Australia, New Zealand, Puerto Rico
-
Institut Claudius RegaudSuspendedUnspecified Adult Solid Tumor, Protocol Specific | Chemotherapeutic Agent Toxicity | Renal ToxicityFrance
-
Salzburger LandesklinikenCompletedCarcinoma, Renal Cell | Renal Tumor | Renal Cyst | Renal Malignant TumorAustria
-
University of Texas Southwestern Medical CenterRecruitingRenal Cell Carcinoma | Renal Tumor | Renal Tumor, BenignUnited States
-
Saint Petersburg State University, RussiaCompletedRenal Tumor | Renal Malignant TumorRussian Federation
-
Eisai Inc.CompletedUnspecified Adult Solid Tumor, Protocol SpecificUnited States
-
Centre Hospitalier Universitaire de NīmesCompleted
-
Assiut UniversityRecruiting
-
Fuda Cancer Hospital, GuangzhouCompleted
-
Lukas J HefermehlKantonsspital BadenRecruitingRenal TumorSwitzerland
Clinical Trials on Microwave ablation with Acculis Accu2i pMTA Applicator
-
Chinese PLA General HospitalNot yet recruitingPancreatic Neoplasms | Ablation
-
Henan Provincial People's HospitalNot yet recruiting
-
Duke UniversityActive, not recruitingNeoplasm Metastasis | Pancreatic Neoplasms | Liver MetastasesUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingStage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Lung Non-Small Cell Carcinoma | Stage III Lung Cancer AJCC v8 | Stage IV Lung Cancer AJCC v8 | Stage II Lung Cancer AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Stage IIB Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung... and other conditionsUnited States
-
Fudan UniversityUnknownOligometastasis | Pancreatic Cancer Metastatic to LiverChina
-
Sherief Abd-ElsalamTanta UniversityRecruiting
-
Médecins Sans Frontières, FranceHarvard Medical School (HMS and HSDM); Institute of Tropical Medicine, Belgium and other collaboratorsCompletedTuberculosis, Multidrug-Resistant | Infection, Bacterial | Pulmonary TuberculosesPakistan, Georgia, India, Kazakhstan, Lesotho, Peru, South Africa