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Procedure
Cryoablation for Early-Stage Breast Cancer (DCIS Trial)
N/A
Recruiting
Research Sponsored by Glendale Adventist Medical Center d/b/a Adventist Health Glendale
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No history of breast radiation in the same breast
No prior history of DCIS or invasive breast cancer in the same breast
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
DCIS Trial Summary
This trial is testing whether cryoablation, or freezing tumors, is an effective alternative to surgery for early-stage breast cancer and small areas of DCIS.
Who is the study for?
This trial is for individuals with a condition called Ductal Carcinoma In Situ (DCIS) in the breast, who haven't had surgery or radiation on the same breast. They should not be pregnant or have been pregnant in the last 6 months and must have enough breast volume for cryoablation. The DCIS should span 2 cm or less as seen on mammography or MRI.Check my eligibility
What is being tested?
The trial is testing cryoablation, which involves freezing tumor cells as an alternative to traditional surgery. It's being studied to see if it can completely destroy small areas of DCIS without needing surgical removal.See study design
What are the potential side effects?
Cryoablation may cause side effects such as pain at the treatment site, swelling, skin changes, and possible damage to nearby tissues due to freezing.
DCIS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have never had radiation therapy on the same breast.
Select...
I have never had breast cancer or DCIS in the same breast before.
Select...
I have not had a biopsy or lumpectomy in the same breast.
Select...
My breast cancer is 2 cm or smaller, confirmed by mammogram or MRI.
Select...
My breast cancer was diagnosed with a needle biopsy.
DCIS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Noninfiltrating Intraductal Carcinoma
Secondary outcome measures
Recurrence rate
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%
UTI
3%
Right shoulder pain (Pain in extremity)
3%
Other, Infectious diarrhea
3%
Gum infection
3%
Right neck pain
3%
Right apical pneumothorax
3%
Arthritis
3%
Peripheral sensory neuropathy
3%
Hiccups
3%
Other, Motor deficit, right side
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%
Right pneumothorax
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
DCIS Trial Design
1Treatment groups
Experimental Treatment
Group I: CryoablationExperimental Treatment1 Intervention
Phase I, single-arm study to evaluate the ability of cryoablation to achieve complete ablation of DCIS in the cryoablation zone of necrosis as a potential alternative to surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cryoablation
2016
Completed Phase 2
~1040
Find a Location
Who is running the clinical trial?
Helen Rey Breast Cancer Research FoundationUNKNOWN
Doterra Healing Hands FoundationUNKNOWN
California Oncology Research InstituteUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have never had radiation therapy on the same breast.I have never had breast cancer or DCIS in the same breast before.I have not had a biopsy or lumpectomy in the same breast.My breast cancer is 2 cm or smaller, confirmed by mammogram or MRI.My breast cancer was diagnosed with a needle biopsy.
Research Study Groups:
This trial has the following groups:- Group 1: Cryoablation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
What is the cap on participants in this medical experiment?
"Affirmative. Clinicaltrials.gov displays that this ongoing medical trial, which was initially advertised on November 1st 2021, is presently seeking participants. Approximately 30 patients need to be enrolled from a solitary clinical site."
Answered by AI
Are researchers currently seeking participants for this research endeavor?
"Affirmative, the information published on clinicaltrials.gov attests that this scientific experiment is currently enrolling participants. It was first made available to the public on November 1st 2021 and its details were last modified on January 28th 2022. The study requires 30 individuals at one medical centre for full participation."
Answered by AI
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