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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
Must not have
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant women are excluded from this study because immune checkpoint inhibitors have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with immune checkpoint inhibitors, breastfeeding should be discontinued.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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I have a cancer lesion that can be measured with a scan.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
Select...
I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Therapeutic procedure
Radiologic Response Rate Of Cryoablation

Side effects data

From 2022 Phase 2 trial • 30 Patients • NCT04118166
50%
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%
UTI
3%
Allergic reaction
3%
Neuropathy under R axilla
3%
Nasal congestion
3%
Other, Motor deficit, right side
3%
L eye pain
3%
Hiccups
3%
Pain
3%
Intermittent brief blurry vision
3%
Other, Lack of appetite
3%
Other, Occasional twitching sensation to anterior chest wall
3%
Insomnia
3%
Pneumonitis
3%
Right neck pain
3%
Worsening anxiety
3%
Gum infection
3%
Dizziness
3%
Shortness of breath with exertion
3%
Pneumothorax
3%
Hoarse voice
3%
Peripheral sensory neuropathy
3%
Muscle weakness, left-sided
3%
Other, Neuropathic pain
3%
Respiratory failure
3%
Anxiety
3%
Other, Motor deficit, left side
3%
Arthralgias
3%
Other, Corneal abrasion
3%
L eye redness
3%
Confusion
3%
Right shoulder pain (Pain in extremity)
3%
Other, Intermittent bilateral hand numbness
3%
Other, Intermittent left sciatic pain
3%
Pleural effusion
3%
Arthritis
3%
Right pleural effusion
3%
Intermittent chills followed by hot flashes
3%
Muscle weakness
3%
Muscle weakness, right-sided
3%
Chest wall pain
3%
Other, Infectious diarrhea
3%
Right apical pneumothorax
3%
Intermittent abdominal bloating
3%
Worsening left leg weakness
3%
Muscle and joint aches
3%
Worsening cough
3%
Right pneumothorax
3%
Lower back throbbing pain
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
2017
Completed Phase 2
~1030
Biopsy
2014
Completed Phase 4
~1150

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,026 Previous Clinical Trials
13,413,759 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

Cryoablation 2023 Treatment Timeline for Medical Study. Trial Name: NCT03290677 — N/A
~4 spots leftby Jan 2026
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