- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06891183
Percutaneous Thermal Ablation in Lung Tumors (Radiofrequency)
Percutaneous Thermal Ablation in Treatment of Lung Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The incidence of lung cancer is one of the highest in the world. In Egypt lung cancer is the third common cancer and the most lethal malignancy in egypt . Where it is responsible for 16.9% and 3.8% of all cancers in males and females respectively.
Surgery is universally accepted as the best choice of therapy in stage 1 non small lung cancer , this is based on favourable outcomes observed in patients who have been surgically treated. However surgery is often high risk procedure because of several comorbidities affecting this cohort of patients.
Therefore non invasive local treatment that makes it possible to avoid resection of functioning parenchyma or prolonged general anaethesia representa key point in management of patients who are not eligible for surgery.
The ablative technologies utilize several sources of energy and different devices to damage targeted tissue using either radio frequency ablation (RFA) or microwave ablation (MWA) which are mini-invasive procedures as they deliver energy to tumour through single or multiple percutaneous needles.
The goal of TA is to induce targeted tissue damage by heating cells to +60 celsius to obtain a complete necrosis of tumour and surrounding tissue, TA may be performed under either conscious sedation or general anaethesia to avoid pain caused by needle insertion and tissue heating.
Computed tomography is today only accurate image guidance method for lung TA, CT guarantees a direct post-procedure .evaluation of ablation, and ground glass opacity is an indicator of extent of ablation achieved to tumour
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Abdulrahman F Ali, Bachelor
- Phone Number: 1200742058
- Email: Abdulrahman_farid@hotmail.com
Study Locations
-
-
-
Assiut, Egypt, 71511
- Recruiting
- Faculty of Medicine
-
Contact:
- Abdulrahman F Ali, Resident
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- lung cancer smaller than 5 cm
- metastasis to the lung
- patients with lung cancer and multiple comorbidities who are unfit for surgery
Exclusion Criteria:
- lung cancer larger than 5 cm
- lung cancer stage II or more
- patients who cannot tolerate CT guided needle placement for thermal ablation of lung tumors
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients
Thermal ablation of lung tumors
|
Percutaneous radiofrequency ablation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accuracy and success
Time Frame: 1 year
|
Determination of tumor size in cm after thermal ablation in treatment of patients who are unfit for surgery or have tumors smaller than 5 cm or metastasis to the lung
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Abdulrahman F Ali, Assiut University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Radiofrequency ablation
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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