MRI with ASL for Carcinoma

Phase-Based Estimates
1
Effectiveness
1
Safety
UT Southwestern Medical Center, Dallas, TX
Carcinoma+2 More
MRI with ASL - Procedure
Eligibility
18+
All Sexes
Eligible conditions
Carcinoma

Study Summary

Non-Contrast Perfusion Using Arterial Spin Labeled MR Imaging for Assessment of Therapy Response in Metastatic Renal Cell Carcinoma

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Eligible Conditions

  • Carcinoma
  • Carcinoma, Renal Cell
  • Renal Cell Adenocarcinoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether MRI with ASL will improve 2 primary outcomes and 2 secondary outcomes in patients with Carcinoma. Measurement will happen over the course of Baseline.

Baseline
ASL measured perfusion within enhancing tumor
Day 14
Change in perfusion in the tumor
Up to 3 years
Overall Survival (OS)
Progression Free Survival (PFS)

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
RCC Patients

This trial requires 90 total participants across 2 different treatment groups

This trial involves 2 different treatments. MRI With ASL 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.

RCC Patients
Procedure
Patients with locally advanced or metastatic renal cell carcinoma
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 3 years for reporting.

Who is running the study

Principal Investigator
A. M.
Prof. Ananth Madhuranthakam, Director of MR Research and Associate Professor
University of Texas Southwestern Medical Center

Closest Location

UT Southwestern Medical Center - Dallas, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Carcinoma or one of the other 2 conditions listed above. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
People with renal cell carcinoma that is located in one area or has spread to other areas of the body. show original
Any woman who is potentially able to have children must agree to a urine pregnancy test as a standard procedure in the radiology department show original
will receive a questionnaire about their spiritual beliefs Patients will be asked about their spiritual beliefs before they undergo anti-angiogenic treatment or immunotherapy. show original
The Eastern Cooperative Oncology Group (ECOG) has three levels of status: 0, 1, and 2 show original
The ability to understand and willingness to sign a written informed consent are required in order to participate in this study. show original

Patient Q&A Section

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

Have there been other clinical trials involving mri with asl?

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The initial results were not as promising as previously thought by the authors. The authors think that this is due in part to the low dose delivered to the liver by the ASL.

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Can carcinoma be cured?

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A small percentage of patients with inoperable carcinoma will go into remission. Patients who obtain complete remission from a malignancy will usually relapse, but often within 5 years after initial remission. Survival varies widely and is probably greatest in patients with early cancers and the most frequent and well-differentiated types.

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What is carcinoma?

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This disease is a cancer that is typically formed from skin, bone, or soft tissue. It is much less common, however, than some other forms of cancer. There is a significant racial difference in the incidence of carcinoma for white women and black women compared with white men with one of the three types of skin cancer and black men compared with white men and black women with breast cancer.

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What causes carcinoma?

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All carcinomas have the same components as other cancer types, just arranged differently. However, as carcinoma has many different subgroups, different specific mechanisms may be involved.

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What are common treatments for carcinoma?

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A wide variety of treatments can be used to treat carcinoma. Radical surgery and radiation therapy can be combined to provide an individualized treatment approach. Patients with liver, breast and proctocolectal carcinoma should be more fully evaluated to identify comorbidities which may be amenable to specific therapy.

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

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The American Cancer Society estimates there will be 824,990 new cases of breast and [cervical cancer](https://www.withpower.com/clinical-trials/cervical-cancer) and 2,620,990 cases of colon, rectal, and anal cancer that will be diagnosed and 278,530 people who will die of the disease in the year 2011.

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What are the signs of carcinoma?

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Carcinomas can present as either early stage or unresectable, metastatic or incurable. The primary tumour site and pattern of dissemination are of great importance for diagnosis and treatment. Symptoms include unexplained weight loss and abnormal weight gain. For lymph node dissemination it is important to look for the presence of enlarged lymph nodes and/or peripheral infiltrations on physical examination, or a high inflammatory response (raised CRP/ESR or elevated Tissue Transglutaminase (tTG) or NSE), and/or elevated levels of CEA, CA 19-9 or CA 125, or a raised CEA/TS ratio.

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How does mri with asl work?

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By using the standard (1¼-inch-diameter) [MRI scanner (1.7 T) for 3×3-minute scan sequences in patients with stage I NSCLC, or (3D) MRI in patients with advanced NSCLC] with asl signal enhancement or washout as an imaging biomarker, the overall detection rate was enhanced by as much as 4-fold. In addition, our new strategy would be extremely useful in the diagnosis of unsuspected stage I NSCLC as well as in follow-up cancer, even when MRCP or B-dominant images do not reveal metastasis.

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How serious can carcinoma be?

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The tumour may be serious and the person may have many problems, but many people do recover from their disease. There are also those who suffer from their cancer. In all, about 5-10% of patients will eventually die of their cancer. Those who live the longest from their disease are women aged 50 or above. The chances of surviving the longest are about 1:20, so about 20 people out of every 1,000 will die of their cancer. Most of the cancer in people over 50 is lung cancer, breast cancer and ovarian cancer. The second highest cause of death is cervical cancer. The most common cancer around Christmas is lung cancer, about 1 in 5 deaths. Another common cancer during the winter is colon cancer.

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Is mri with asl typically used in combination with any other treatments?

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The imaging with asl in the early staging of lung cancer is considered to be a good method if a clinical trial is planned in the early years of implementing asl in routine lung cancer patients.

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What are the latest developments in mri with asl for therapeutic use?

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Magnetic resonance imaging (MRI) with a contrast medium such as gadolinium-enhanced T1WI/T2WI has been used by several groups to study the response to treatment, especially to check residual or metastatic disease after (radio)chemotherapy for various solid tumors. More recent studies have utilized MRI data sets obtained during serial clinical follow-up to evaluate both lesion response and tumor progression in various cancers such as nonsmall cell lung cancer, Hodgkin lymphoma, head and neck cancer, advanced non-small cell lung cancer, and colorectal cancer.

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What is the primary cause of carcinoma?

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Cancer may be related to a primary condition in 25% of cases or may involve the same disease. If a primary condition is found to be contributing to the cancer, cancer treatments aimed at it or surgery will not cure the cancer, but it may help control the cancer. This is particularly true for cancers related to smoking, for which the treatment with inhaled cessation agents has been shown to be effective. Smoking remains the only effective way to prevent the development of lung cancer, and cessation of smoking will most probably help prevent cancers related to smoking. For other cancers, treatment of the main contributing disease will generally help prevent relapse of the cancer.

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