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Cryoablation for Lung Cancer
N/A
Waitlist Available
Led By Meghan J Mooradian, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have measurable disease (by RECIST) independent of the lesion to be ablated. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam. See Section 11 for the evaluation of measurable disease.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing if cryoablation, a treatment to kill cancer cells with extreme cold, combined with a current immune checkpoint inhibitor, is an effective treatment for lung cancer.
Who is the study for?
This trial is for adults over 18 with stage IV lung cancer who are already on immune checkpoint inhibitor therapy but have seen their disease progress. They must have a tumor that can be measured and treated with cryoablation, and they should be able to continue their current treatment for an additional 4-6 weeks.Check my eligibility
What is being tested?
The study is testing the combination of cryoablation (using extreme cold to destroy cancer cells) with ongoing immune checkpoint inhibitor therapy in patients whose lung cancer has progressed despite treatment.See study design
What are the potential side effects?
Potential side effects may include pain at the site of cryoablation, risk of bleeding or infection from biopsy, tissue damage due to freezing, general side effects from immune checkpoint inhibitors like fatigue, skin reactions, or flu-like symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a cancer lesion that can be measured with a scan.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Therapeutic procedure
Radiologic Response Rate Of Cryoablation
Side effects data
From 2022 Phase 2 trial • 30 Patients • NCT0411816650%
Other, Disease Progression (death)
30%
Fatigue
23%
Cough
17%
Constipation
17%
Nausea
17%
Pruritis
13%
Anemia
13%
Hypothyroidism
13%
Abdominal pain
13%
Fever
13%
Weight loss
13%
Rash
10%
Dyspnea
10%
Productive cough
10%
Hyperthyroidism
10%
Diarrhea
10%
Other, Decreased appetite
7%
Abdominal bloating
7%
Headache
7%
Elevated ALT
7%
Elevated AST
7%
Intermittent heart palpitations
7%
Tachycardia
7%
Dry mouth
7%
Intermittent nausea
7%
Hyponatremia
7%
Other, Pain to right chest wall at recent site of cryo
7%
Wheezing
3%
Gum infection
3%
Right shoulder pain (Pain in extremity)
3%
Other, Infectious diarrhea
3%
UTI
3%
Arthritis
3%
Right neck pain
3%
Right pneumothorax
3%
Peripheral sensory neuropathy
3%
Hiccups
3%
Other, Motor deficit, right side
3%
Right apical pneumothorax
3%
Intermittent brief blurry vision
3%
Pain
3%
Other, Corneal abrasion
3%
Other, Motor deficit, left side
3%
Worsening anxiety
3%
Arthralgias
3%
Dizziness
3%
Confusion
3%
Anxiety
3%
Insomnia
3%
Other, Lack of appetite
3%
Pneumonitis
3%
Pneumothorax
3%
Intermittent abdominal bloating
3%
L eye redness
3%
Right pleural effusion
3%
L eye pain
3%
Other, Neuropathic pain
3%
Intermittent chills followed by hot flashes
3%
Allergic reaction
3%
Muscle weakness
3%
Muscle and joint aches
3%
Chest wall pain
3%
Lower back throbbing pain
3%
Worsening left leg weakness
3%
Muscle weakness, left-sided
3%
Other, Intermittent left sciatic pain
3%
Muscle weakness, right-sided
3%
Other, Intermittent bilateral hand numbness
3%
Neuropathy under R axilla
3%
Other, Occasional twitching sensation to anterior chest wall
3%
Respiratory failure
3%
Worsening cough
3%
Shortness of breath with exertion
3%
Hoarse voice
3%
Nasal congestion
3%
Pleural effusion
3%
Chest Pain
3%
Keratitis
3%
Tension pneumothorax (requiring ICU stay)
3%
Depression
3%
Sore throat
3%
Cardiac arrest
3%
Adrenal insufficiency
3%
Blood bilirubin increased
3%
Alkaline phosphatase increased
3%
Hematuria
3%
Proteinuria
3%
Intermittent bronchopulmonary hemorrhage
3%
Shortness of breath
3%
Hypoxia
3%
Other, Deep vein thrombois (DVT) of catheter
3%
Atrial fibrillation
3%
Pericarditis
3%
Sinus tachycardia
3%
Other, Decreased pulse
3%
Ringing in the ears (tinnitus)
3%
Hypophysitis
3%
Dry eyes
3%
Flashing lights
3%
L eye burning sensation
3%
L eye blurred vision
3%
R eye blurred vision
3%
Increased abdominal pain
3%
Diarrhea (intermittent)
3%
Intermittent nausea/vomiting
3%
Vomiting
3%
Other, Mucositis
3%
Intermittent fever
3%
Low grade fever
3%
Flu-like symptoms
3%
Intermittent chest pain to R sternal border exacerbated with deep inhalation
3%
Intermittent fatigue
3%
Other, Presumed pneumonia
3%
Fall
3%
Creatinine increased
3%
Elevated TSH
3%
TSH increased
3%
Decreased WBC count
3%
Anorexia
3%
Other, Gluteal pain and swelling
3%
Other, Arm pain left
3%
Other, Muscle aches and fatigue associated with COVID vaccine
3%
Other, Right thigh pain
3%
Other, Soreness to right lateral ribs
3%
Other, Soreness at site of recent cryoablation (R lung)
3%
Other, Soreness right chest wall
3%
Other, Soreness to left side at site of recent cryoablation
3%
Other, Soreness, right shoulder
3%
Other, Pelvic bone pain
3%
Other, Intermittent peripheral edema
3%
Other, Weakness to left shoulder
3%
Intermittent hematuria
3%
Blood tinge sputum
3%
Intermittent cough
3%
Intermittent cough w/chest tightness
3%
Intermittent cough with Blood tinge sputum
3%
Dry cough
3%
Other, Hair thinning
3%
Other, Leg ulcer left
3%
Other, Molluscum contagiousum on left arm
3%
Pulmonary embolism
3%
Upper respiratory infection (COVID-19)
3%
Intermittent wheezing
3%
Other, Hemoptysis
3%
Dry skin
3%
Facial rash
3%
Maculo-papular rash
3%
Maculo-papular rash to bilateral arms
3%
Post-inflammatory hyperpigmentation on left breast
3%
Tinea
3%
Other, Burned hand
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ipilimumab/Nivolumab + Cryotherapy
Trial Design
1Treatment groups
Experimental Treatment
Group I: CT-guided Percutaneous Cryoablation of Lung TumorExperimental Treatment2 Interventions
Image-guided core needle biopsy to confirm cancer will be perform
Patients will undergo cryoablation as a standard procedure
cryoablation will be performed with a three-cycle freeze-thaw phase protocol
Non-contrast CT images will be obtained in 3 to 5 minutes intervals to visualize the evolving ablation zone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cryoablation
2016
Completed Phase 2
~1040
Biopsy
2014
Completed Phase 4
~850
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,325 Total Patients Enrolled
William M. Wood FoundationUNKNOWN
1 Previous Clinical Trials
37 Total Patients Enrolled
Meghan J Mooradian, MDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
37 Total Patients Enrolled
Media Library
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are engaged in this research?
"Affirmative. Per the information on clinicaltrials.gov, this clinical trial is still recruiting volunteers. This study was first posted on January 17th 2018 and updated most recently in February 2021. The goal of this experiment is to enroll 20 patients across one site."
Answered by AI
Is this research endeavor presently admitting new participants?
"Affirmative. According to clinicaltrials.gov, this trial is currently open for enrollment and was first posted on January 17th 2018 with its last edit occuring February 22nd 2021. The study requires 20 participants from one site."
Answered by AI
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