Status:

UNKNOWN

Microwave Ablation of Primary and Secondary Lung Malignancies

Lead Sponsor:

University of Calgary

Conditions:

Lung Neoplasms

Neoplasm Metastasis

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

Brief Summary

Surgery is the first choice of treatment for early-stage primary pulmonary malignancies, but up to 15% of all patients, and 33% of patients greater than 75 years of age, are not surgical candidate's d...

Eligibility Criteria

Inclusion

  • Non-Small Cell Lung Carcinoma and metastatic lesions from lung, colorectal, breast, sarcoma, melanoma
  • Patient median estimate survival of \> 1 year, as determined by the treating physician
  • ECOG 0-1
  • \<5 lesions in either lung
  • Limited and/or controlled extra-pulmonary disease - to be determined by multidisciplinary consensus
  • Not amenable to surgery, SBRT or chemotherapy (or patient refusal)
  • Patient will have documentation by surgeon and/or radiation oncologist that the patient is unamenable to surgery and SBRT

Exclusion

  • Lesions \>3cm in size
  • Lesions within 1 cm of any critical mediastinal structure (e.g. aorta, main pulmonary arteries, esophagus, phrenic nerve), diaphragm or pleura
  • FEV1≤35% predicted
  • Clinically significant emphysema (to be determined by the treating physician)
  • Previous pneumonectomy
  • Inability to tolerate pneumothorax as judged by referring clinician's clinical assessment
  • Inability to tolerate general anaesthetic
  • Inability to provide informed consent
  • INR \> 1.5
  • Platelets \< 100
  • PTT \> 40

Key Trial Info

Start Date :

May 1 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2022

Estimated Enrollment :

35 Patients enrolled

Trial Details

Trial ID

NCT04369872

Start Date

May 1 2020

End Date

December 31 2022

Last Update

November 9 2020

Active Locations (1)

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1

Foothills Medical Centre

Calgary, Alberya, Canada, T2N2T9