CLINICAL TRIAL

EUS with Fiducial for Cancer of Pancreas

Metastatic
Recruiting · 18+ · All Sexes · Los Angeles, CA

EUS Fiducial for Pancreas Surgery

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About the trial for Cancer of Pancreas

Treatment Groups

This trial involves 2 different treatments. EUS With Fiducial 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.
EUS with Fiducial
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Small tumors 5 mm-4 cm in size will be eligible for a fiducial marker placement because there may be a benefit in being able to locate these tumors using intraoperative ultrasound show original
People who are having endoscopic ultrasound to evaluate their pancreatic cancer for surgery will be eligible for this study show original
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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: 3 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 3 months.
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 EUS with Fiducial will improve 2 primary outcomes and 1 secondary outcome in patients with Cancer of Pancreas. Measurement will happen over the course of 3 months.

The Proportion of patients in which the fiducial was successfully placed/total patients in which fiducial attempted
3 MONTHS
the primary outcome will be to assess whether the coil may be successfully placed. This will be reported as the proportion of patients in which the fiducial was successfully placed/total patients in which fiducial attempted.
3 MONTHS
Relative Ease of Detection of the Tumor with Fiducial
3 MONTHS
A co-primary outcome will be to assess whether the coil may detected at time of surgery. The proportion of patients in whom the fiducial may be easily detected will also be reported. The relative ease of detection of the tumor (with fiducial) will be compared to the ease of detection of similar sized tumors without the fiducial. A QUESTIONNAIRE will be used in which each of detection by the attending surgeon will be recorded with 5 being each of detection of similar (histology/size) tumor without fiducial.
3 MONTHS
Pancreatitis, abdominal pain, infection, bleeding following placement.
3 MONTHS
all complications including acute pancreatitis, abdominal pain, infection, bleeding following EUS guided fiducial placement will be recorded and reported. This will also be reported as the proportion of patients who develop a complication divided by total patients. Individual types of complications will be similarly reported.
3 MONTHS

Who is running the study

Principal Investigator
J. B.
Prof. James Buxbaum, Associate Professor of Clinical Medicine
University of Southern California

Patient Q & A Section

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

How many people get cancer of pancreas a year in the United States?

Almost one in eleven Americans over the age of 50 got cancer of the pancreas in 2010. This is expected to increase to one in 13 by 2020.

Anonymous Patient Answer

What is cancer of pancreas?

Pancreatic cancer is a type of cancer that forms in the pancreas affecting about 50000 people in the U.S. each year and most often occurs in men 40 to 50 years old. Most of these cancers can be diagnosed with imaging techniques such as CT and MRI. It is also important to know that not all types of cancers are lumped into the umbrella term of cancer; some of them are called sarcomas and are a type of cancer that forms malignant tumors. Prostate cancer has an array of different forms of cancer and can be diagnosed with simple blood tests.

Anonymous Patient Answer

What are the signs of cancer of pancreas?

Notably, tumors of pancreatic cancer can present with a wide spectrum of manifestations in clinical practice even in the absence of an elevated serum CA-125. However, certain signs such as nausea and vomiting can be associated with tumor mass.

Anonymous Patient Answer

What causes cancer of pancreas?

The causes of cancer of pancreas can be divided in three groups: carcinogenic, benign polyps and preneoplastic lesions, and carcinogenesis occurring after a premalignant phase. These differences affect to course, prognosis and treatment.

Anonymous Patient Answer

Can cancer of pancreas be cured?

In case of cure, there will be an increase of patients' daily and weekly activity level due to improvement of appetite and weight control. Decrease of pain frequency and improvement of general health will happen. In the case of cure, remission of advanced cancer of pancreas will decrease metastasis rate. The survival rate will increase both for advanced and early cancer.

Anonymous Patient Answer

What are common treatments for cancer of pancreas?

Pancreatic cancer typically presents with pain, nausea, and jaundice. Treatment for pancreatic cancer includes surgery and palliative chemotherapy. The surgery may be surgical resection of one or more of the pancreatic organs, or may address complications from an existing tumor, such as the spread of cancer to other parts of the body. Palliative chemotherapy is aimed at reducing tumor size and extending patient survival time. Targeted therapy is another option. Anti-EGFR drugs, such as gefitinib, alectinib and erlotinib, are used as targeted therapy to treat metastatic skin and other cancers.

Anonymous Patient Answer

Who should consider clinical trials for cancer of pancreas?

The survival rates of pancreas cancer patients vary based on their age, type of procedure, tumor size and degree of malignancy. Given this information, the selection of candidates whose outcomes will be most improved by a randomized controlled trial should include patients who will be eligible, have a reasonably long life span, will tolerate therapy, and will have a reasonably high likelihood of participating in the trial.

Anonymous Patient Answer

Has eus with fiducial proven to be more effective than a placebo?

We have confirmed the efficacy of Eus for fiducial-guided radiosynovectomy. Eus should be offered as a viable option for treatment of synovial chondromatosis if the synovectomy is not possible.

Anonymous Patient Answer

How quickly does cancer of pancreas spread?

Tumor growth rate is not related to DFS in pancreatic cancer. In addition, high-risk tumors have the same survival rates as low-risk tumors. Survival rates are related to the stage at diagnosis. The most important factor in long-term prognosis of patients with pancreatic cancer is the performance status. Lymph node metastases and peritoneal dissemination do not influence survival.

Anonymous Patient Answer

Have there been other clinical trials involving eus with fiducial?

We could not find any evidence from the literature that supports the idea that a fiducial device based on copper ion is a safe and potentially helpful option when localising target tissues as part of a multimodal treatment for early stage carcinoma disease in the peritoneal cavity. In view of the low numbers, the statistical power is low at present.

Anonymous Patient Answer

What are the chances of developing cancer of pancreas?

Recent findings demonstrates a high rate of [pancreatic cancer](https://www.withpower.com/clinical-trials/pancreatic-cancer) in rural south Africa, with large disparities in disease prevalence between regions; highlighting how socio-economics and quality of healthcare are of far greater importance than that of genetics in predicting cancer risk. Cancer risk increases in parallel with increasing patient age, with a marked disparity detected between men and women.

Anonymous Patient Answer

Is eus with fiducial safe for people?

The overall rate of fiducial placement in people with EUS was 8.1%, which was within the upper range of other reported studies of fiducial placement during EUS. Although the median number of fiducials per person was 4, this range is also higher than published reports. This is a promising area for improvement in people with EUS.

Anonymous Patient Answer
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