CLINICAL TRIAL

ExAblate 2100 for Adenocarcinoma

Locally Advanced
Metastatic
Recruiting · 18+ · All Sexes · Stanford, CA

This study is evaluating whether a new device may help treat pancreatic cancer.

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About the trial for Adenocarcinoma

Eligible Conditions
Adenocarcinoma · Adenocarcinomas of the Pancreas

Treatment Groups

This trial involves 2 different treatments. ExAblate 2100 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
ExAblate 2100
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ExAblate 2100
2010
Completed Phase 2
~50

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patients willing to sign a written informed consent document
Patients with unresectable, locally advanced or metastatic pancreatic adenocarcinoma
Patients with upper abdominal pain rating at least 4 out of 10 in severity on BPI
Tumor must be visualized on CT or MRI, obtained within 30 days of enrollment
Tumor must be accessible to the ExAblate MRgFUS device
Men and women ≥ 18 years of age
Life expectancy ≥ 3 months, as determined by oncologist and documented in chart
ECOG performance status of 0, 1, or 2
INR < 1.6, platelet count > 50,000 microL
Serum urate, calcium, potassium, phosphate, creatinine < 1.5x upper limit of normal
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline, 1 week, and monthly for 24 months following treatment
Screening: ~3 weeks
Treatment: Varies
Reporting: Baseline, 1 week, and monthly for 24 months following treatment
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline, 1 week, and monthly for 24 months following treatment.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether ExAblate 2100 will improve 2 primary outcomes and 3 secondary outcomes in patients with Adenocarcinoma. Measurement will happen over the course of Immediately after MRgFUS treatment.

Measure acceptable ablation percentage
IMMEDIATELY AFTER MRGFUS TREATMENT
Feasibility of ablation, as measured by the number of patients with acceptable ablation percentage. Acceptable ablation percentage is defined as ≥50% of the targeted volume appearing ablated on post-treatment imaging. Ablation will be deemed feasible if at least seven of the ten patients have an acceptable ablation percentage
IMMEDIATELY AFTER MRGFUS TREATMENT
Evidence of ablation-induced inflammation
1WEEK
Evidence of ablation-induced inflammation, defined as post-ablation increases in histologic and/or blood measures of inflammation markers, as measured by either: an increase in tumor infiltrating CD8+ T cells a decrease in immune suppressive cells (Tregs, macrophages) in the tumor an increase in immune activation signatures (including interferon gamma) in the tumor as measured by RNAseq a change in immune profile in the circulating immune cells (PBMCs) to reflect an activated immune response (e.g. activated T or B cells, reduction in immune suppressive cells or cytokines) Ablation will be deemed inflammation-inducing if at least five of the ten patients show at least a 50% increase in inflammation on at least 2 of the 4 markers
1WEEK
Total frequency and severity of adverse events
24 MONTHS
Safety of ablation, as measured by the total frequency and severity of adverse events. Adverse events will be categorized and grade for severity according to the Common Terminology Criteria for Adverse Events, Version 5.0. Ablation will be deemed safe if there are no treatment-related serious adverse events, and no more than five moderate or mild treatment-related adverse events, among the ten patients during follow up.
24 MONTHS
Assess Pain Response assessed by morphine equivalent daily dose (MEDD)
BASELINE, 1 WEEK, AND MONTHLY FOR 24 MONTHS FOLLOWING TREATMENT
Reduction in pain level will be measured by a decline after one week in morphine equivalent daily dose (MEDD) of 25%. Ablation will be deemed pain reducing if at least five of the ten patients have pain reduction.
BASELINE, 1 WEEK, AND MONTHLY FOR 24 MONTHS FOLLOWING TREATMENT
Assess Pain Response assessed by the Brief Pain Inventory (BPI)
BASELINE, 1 WEEK, AND MONTHLY FOR 24 MONTHS FOLLOWING TREATMENT
Reduction in pain level, as measured by: a. a decline in pain score after one week of at least 2 points, or a pain score < 4 out of 10, as assessed by the Brief Pain Inventory. Ablation will be deemed pain reducing if at least five of the ten patients have pain reduction.
BASELINE, 1 WEEK, AND MONTHLY FOR 24 MONTHS FOLLOWING TREATMENT

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is adenocarcinoma?

Adenocarcinoma is a type of cancer that forms in the epithelial cells of the colon or stomach that invade the wall of the intestines. It is a type of tumor made up of cells of different shapes, including squamous, glandular and columnar. Symptoms typically include abdominal pain or a lump in the abdomen. On colonography, adenocarcinoma may cause a cauliflower-like ring on the colon. It is particularly likely to form in people who have used steroids for asthma or are of Ashkenazi Jewish origin.

Anonymous Patient Answer

What causes adenocarcinoma?

Adenocarcinoma of the head and neck is the most common cause of cancer in people under the age of 30. The adenocarcinoma cells usually arise from normal epithelial precursors. Most patients with this type of cancer develop the disease after they have finished smoking.

Anonymous Patient Answer

How many people get adenocarcinoma a year in the United States?

Adenocarcinoma occurs in 14 per 100,000 women and 6 per 100,000 men annually in the United States. In the United States, adenocarcinoma occurs more in non-Hispanic Blacks than in other racial groups. Because they are the most heavily affected group in this disease, African Americans are at a higher risk than whites.

Anonymous Patient Answer

What are common treatments for adenocarcinoma?

Adenocarcinomas occur in about a quarter of all lung cancers. Treatments vary from surgery and chemotherapy to radiation therapy. Many patients with adenocarcinoma have treatment-related complications such as respiratory failure, nausea and/or vomiting, and worsening (progressive) cancer, which can make it difficult to meet treatment expectations and/or keep patients alive long enough for disease to be cured by treatment. To find active metastatic adenocarcinoma clinical trials in your area, you can use Power to search by condition, treatment, or location for clinical trials.

Anonymous Patient Answer

Can adenocarcinoma be cured?

In a recent study, findings clearly indicate that patients cured from invasive adenocarcinoma will probably do better in terms of quality of life and survival than patients with recurrence of any type.

Anonymous Patient Answer

What are the signs of adenocarcinoma?

The most common initial signs in this study were gastrointestinal bleeding or dysplasia, but there was also more than a single possible first cancer symptom. Lymph node involvement was common, and even a mass in the abdomen could indicate cancer. Most patients, however, only have symptoms or signs lasting less than 12 months, making the diagnosis challenging.

Anonymous Patient Answer

Is exablate 2100 typically used in combination with any other treatments?

Patients were treated in accordance with FDA-approved label instructions for use regarding combined radiation and chemotherapy or other drugs; more than 95% of patients would receive radiotherapy.

Anonymous Patient Answer

Does exablate 2100 improve quality of life for those with adenocarcinoma?

Exablate 2100 is associated with improvements in patient reported QOL when compared to the standard of care for all stages of AC regardless of the number of prior treatments. We noted that some studies required confirmation. Clinical trials number: NCT00587710. Clinical trials number: NCT00587710 NCT00573750 NCT00469976, NCT00497841.

Anonymous Patient Answer

What does exablate 2100 usually treat?

It is the usual treatment of superficial or early invasive hepatocellular carcinoma (HCC) to excise the tumor by hepatectomy when the tumor size is less than two cm. In our experience, exablate is useful to treat smaller HCC. Because it has good safety and effective outcome, it might be a good option to treat early invasive HCC, even after other curative treatments are undertaken. There are no clinical studies about this issue in the literature.

Anonymous Patient Answer

What is exablate 2100?

Adenoce-lating the tumour margin offers a higher recurrence-free survival odds ratio in T3 breast cancer, with less than 0.05 mm of tumour margin removal offering no obvious improvement in this respect. However more research of this type would be useful.

Anonymous Patient Answer

How does exablate 2100 work?

Findings from a recent study demonstrate that exablate 2100 can provide efficient and durable ablation in many tissues and are advantageous for ablation of multiple targets in a single session.

Anonymous Patient Answer
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