Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Thalidomide

Immunosuppressive Agents

Immunologic Factors

Anti-Bacterial Agents

Angiogenesis Inhibitors

Growth Inhibitors

Yu-Chieh Yu, R.N.

Hui-Ju Ch'ang, M.D.

Chih-Hung Hsu, M.D.

Tiffany Ting Fang Shih, M.D.

This is a pilot study of concomitant radiotherapy and thalidomide for patients with locally advanced HCC.Besides toxicity and efficacy, mechanistic studies including dynamic contrast enhanced MRI and serum cytokines will be evaluated.

This is a pilot study of concomitant radiotherapy and thalidomide for patients with locally advanced HCC. Patients whose tumor(s) are not suitable for other local treatment, such as surgery, trans-arterial chemoembolization (TAE), ethanol injection, or radiofrequency ablation. will be enrolled.Radical radiotherapy will be started after pre-treatment evaluation. The total dose of RT will be 50Gy in 25 fractions to local tumor(s). Oral Thalidomide will be started 3 days before RT begins. Thalidomide treatment will continue for totally 6 months or until tumor progression. Dynamic contrast enhanced MRI (DCEMRI) will be done at the following time points to assess the change in tumor perfusion: (1) before the start of thalidomide treatment; (2) 3 days after thalidomide before radiotherapy; (3) 2weeks after radiotherapy begins;and (4) 1 month after radiotherapy completes. DCEMRI will then be done every 3 months until disease progression.Serum samples for angiogenic cytokine studies will also be collected.The study was designed to evaluate the feasibility and tolerability of combination treatment of radiotherapy and thalidomide for locally advanced HCC. The sample size was determined by the expected incidence of grade 4 toxicity of the combination treatment versus radiotherapy alone for locally advanced HCC. Since the grade 4 toxicity of radiotherapy alone is 7-9%, we need at least 15 patients to evaluate for feasibility of the combination treatment. With an estimated drop out rate of approximately 10%, 17 patients will be enrolled.

Radiotherapy Plus Thalidomide in Locally Advanced Hepatocellular Carcinoma

A Pilot Clinical and Mechanistic Study of Radiotherapy Plus Thalidomide in Locally Advanced Hepatocellular Carcinoma

National Health Research Institutes, Taiwan

National Taiwan University Hospital

Symptoms and General Pathology

Colorectal Neoplasms

Body Weight

Neoplasm Metastasis

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Hematinics

Bevacizumab

Liver Extracts

Eligible participants in Arm A enrolled in this imaging study will: be older than 18, have metastatic colorectal cancer with at least one hepatic lesion, and be treated with FOLFOX in combination with bevacizumab.

Eligible participants in Arm B enrolled in this imaging study will: be older than 18, must have prior histological documentation of any types of cancer with metastasis to the liver, and must be in stable treatment conditions prior to and between scans.

Participants will receive two (2) dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) prior to chemotherapy and one (1) DCE-MRI after the first cycle of chemotherapy. Participants will be followed for up to 2 years after the initiation of chemotherapy or until disease progression.

DCE-MRI

Mark Rosen, MD, PhD

Larry Dougherty, PhD

Donald Mitchell, MD

Peter J O'Dwyer, MD

Michael D Feldman, MD, PhD

The objectives for this study include:

* Testing a unique way of imaging people with colorectal cancer and other cancers that has spread to the liver using magnetic resonance imaging (MRI);
* Seeing if the MRI process can be used across multiple imaging platforms;
* Determining whether the results of the imaging can be reproduced;
* Reviewing how MRI results relate to cancer response to combination therapy and to clinical endpoints.

This study will investigate the use of projection reconstruction dynamic contrast-enhanced MRI (DCE-MRI) as a surrogate marker of tumor vascularity in patients treated with the antiangiogenic agent bevacizumab. DCE-MRI is gaining popularity as a method to assess the functional response of tumors to agents targeting the vascular endothelial growth factor (VGEF) pathways. DCE-MRI measurements have been proposed as a non-invasive measure of both tumor biologic activity and (in the case of antivascular therapy) early response to treatment. A number of phase I and II studies demonstrate the ability for DCE-MRI to detect perfusion changes associated with tumor biologic response to vascularly targeted agents. It has been suggested that pre-treatment DCE-MRI might identify tumors with high intrinsic perfusion and that these tumors will be more likely to respond to antivascular-based therapies. However, the current use of DCE-MRI in clinical settings is challenging. Trade-offs between spatial coverage, time, and spatial resolution make this technique difficult to implement in human studies and may limit its reliability. The use of projection reconstruction-based acquisition can mitigate the need for these trade-offs and can simultaneously provide high temporal and spatial resolution data for DCE-MRI analysis.

Metastatic Colorectal Cancer: Treatment Response With Dynamic Contrast MRI

Angle Interleaved Projection Reconstruction With K-Space Weighted Image Reconstruction for Dynamic Contrast MRI of Cancer Therapy Response

Pennsylvania Department of Health

American College of Radiology

Rare Diseases

Sarcoma

Neoplasms, Connective and Soft Tissue

Soft Tissue Sarcoma

Patients will undergo a baseline MR exam at enrollment within 4 weeks prior to scheduled surgery, which will include DW-MRI and DCE-MRI prior to surgery and tumor tissue collection.

Dynamic Contrast Enhanced MRI (DCE-MRI) and Diffusion Weighted MRI (DW-MRI): DW-MRI is a technique for quantifying the increase in water diffusion caused by cellular necrosis or apoptosis in tumors within days of therapy. DCE-MRI is frequently used in preclinical and early clinical trial assessment of anti-angiogenic and vascular disrupting compounds, also within hours of therapeutic intervention.

DCE and DWI MRI

Standard of care procedure for sarcoma patients

Surgery

Lawrence H Schwartz, MD

Unless a cancer quickly gets smaller with radiation or chemotherapy, the investigators cannot tell if the treatment is working or not. In this research program, two techniques using magnetic resonance imaging (MRI) scanning will be tested in people who have sarcomas, which are rare cancers starting in muscle, tendons, and bones. These particular MRI tests are called dynamic contrast enhanced MRI and diffusion weighted MRI. These MRI scans allow visualization of how sarcomas are different from the normal organs of the body. These MRI tests will tell us the location of sarcoma and its proximity to other structures, as well as correlation of imaging with pathological characteristics after surgery

Dynamic Contrast Enhanced MRI (DCE-MRI) and Diffusion Weighted MRI (DW-MRI) are imaging approaches that are being utilized in preclinical evaluation as well as clinical trials. DW-MRI is a technique for quantifying the increase in water diffusion caused by cellular necrosis or apoptosis in tumors within days of therapy. DCE-MRI is frequently used in preclinical and early clinical trial assessment of anti-angiogenic and vascular disrupting compounds, also within hours of therapeutic intervention. Evidence of drug efficacy and dose-dependent response has been demonstrated with certain angiogenesis inhibitors. It may also provide useful information for identifying early disease progression, independent of the treatment modality. While these approaches provide additional functional information, they have yet to be validated in sarcoma patients. This study seeks to develop a standardized protocol for performing DCE-MRI and DW-MRI and implement this in a clinical trial of patients with sarcomas who will have surgical resection as part of their standard care. This will allow the accuracy of in vivo MRI measurements to be directly compared to histology as ground truth. The study will also determine the reproducibility of these techniques using repeat baseline imaging as well as evaluate the quantitative changes in these parameters before and after therapy and correlate with histopathology. The collaboration between Columbia University and the University of Utah for this project will allow the existing quantitative MRI approaches to be expanded to a multi-center setting, and will establish a paradigm infrastructure for future expansion to larger scale multi-center therapeutic trials in sarcoma.

Quantitative Imaging Biomarkers for Sarcoma

Development of Quantitative Imaging Biomarkers for Evaluating Sarcoma Patients

The primary endpoint of this study is to evaluate the correlation of the estimated in vivo Dynamic Contrast Enhanced and Diffusion weighted MRI parameters with ex vivo histopathologic measurements obtained from tumor tissue. Correlation coefficient (range: -1 to 1).

National Cancer Institute (NCI)

Columbia University

James Picker Professor and Chairman Department of Radiology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Patients who have been diagnosed with prostate cancer and are scheduled to undergo radical prostatectomy and have not received any preoperative treatment for prostate cancer.

Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer.

Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil.

MRI scan

Robert L Grubb, III, M.D.

The purpose of the present study is to find out if MRI techniques examining (1) the motion of water molecules in the prostate (diffusion sensitive MRI), (2) the difference in blood flow to the prostate (dynamic contrast enhanced MRI), and (3) differences in chemical composition of the prostate (MR spectroscopy), can be used to detect prostate cancer early and non-invasively. Localization of the cancer within the prostate would be of particular importance in focal cryoablation of prostate carcinoma which we hope to improve as a result of this project.

Additional aim of the study is to correlate expression of genes believed to pay a role in prostate cancer with MRI findings.

Radical prostatectomy patients will undergo an MRI prior to their scheduled surgery. Ex vivo imaging will be done on prostates once removed. Results from the final pathology with be compared with results of imaging to determine the accuracy of the image analysis in cancer localization and staging.

Brachytherapy patients will undergo an MRI prior to their scheduled procedure. Two areas of suspected cancer and two areas without suspected cancer will be prospectively identified based on the MRI imaging. At the time of brachytherapy, transrectal needle biopsies will be obtained from the previously identified areas. The needle cores will be reviewed by study pathologist to determine the accuracy of the image analysis in cancer localization and staging.

Feasibility Study of Prostate Tumor Localization for Focal Cryoablation of Prostate Carcinoma

Data obtained as part of this study could not be analyzed in a meaningful way due to problems with correlation between the cancerous tissue identified by histology and tissue imaging from imaging.

Ultrasound guidance of transrectal ultrasound biopsy was not attempted.

Midwest Stone Institute.

Washington University School of Medicine

Patients who have been diagnosed with prostate cancer and are scheduled to undergo radical prostatectomy and have not received any preoperative treatment for prostate cancer.

MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil.

Radical Prostatectomy Patients

Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer.

MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil.

Brachytherapy Patients

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Robert Grubb, III

Improved Accuracy of Prostate Cancer Detection by MRI Scan.

Successful MRI Guidance of Transrectal Ultrasound Biopsy in Patients.

Overall Study

Heart and Blood Diseases

Head and Neck Neoplasms

Mitral Valve Insufficiency

Pts undergo DCE-MRI, DW-MRI or 1\^H-MRS studies on either the 1.5T scanner or the 3T MRI scanners. Patients will be grouped based on their treatment: group one will include pts who undergo surgery (we will no longer accrue pts in this group) \& group two will include pts who undergo chemoradiation therapy.Pts who undergo surgery will have pretreatment DCE-MRI, DW-MRI \&/or 1H-MRS studies on the GE 1.5T or 3T MRI scanner. Pts who participate in chemo-radiation therapy protocols will have pretreatment DCE-MRI, DW-MRI \&/or 1H-MRS studies on the 3T Philips MRI scanner in the radiation oncology suite \& will undergo additional recommended weekly DW-MRI including IVIM studies at the same MRI scanner during the course of treatment. Pts will undergo two recommended DCE-MRI studies (unless contraindicated) when possible. 1st intra-treatment DCE-MRI is recommended between the 1st \& 2nd weeks of treatment \& the 2nd intra-treatment DCE-MRI is recommended between the 3rd \& 4th weeks of treatment.

DCE-MRI, DW-MRI and MRS

Amita Dave, PhD

Magnetic resonance imaging (MRI) is a diagnostic study that makes pictures of organs of the body using magnetic field and radio frequency pulses that can not be felt. Dynamic contrast enhanced-magnetic resonance imaging (DCE-MRI) uses faster imaging and contrast material (a substance used to make specific organs, blood vessels, or tumors easier to see) that is given by vein. Diffusion weighted magnetic resonance imaging (DW-MRI) allows to measure the motion of water around the cells in the tumor. Proton magnetic resonance spectroscopy (MRS) obtains chemical information from the tumor. During MRS, signals are detected from the chemicals (spectroscopy) naturally present in your tumor using radio waves. DCE-MRI, DW-MRI and MRS give extra information which is not available with the regular MRI. The regular MRI only shows pictures of the tumor while the DCE-MRI also gives information about the blood vessels of the tumor. DW-MRI provides information related to the state of the tumor tissue with regards to the quality or condition of cells present in it and MRS gives information about the chemical makeup of the tumor.

The purpose of this study is to see whether DCE-MRI, DW-MRI and MRS done before treatment can predict which patients will do well with either surgery or chemo-radiation therapy. This study will also see if DCE-MRI, DW-MRI and MRS done early in treatment can tell if the therapy is working.

Dynamic Contrast Enhanced MRI (DCE-MRI) Diffusion Weighted MRI (DW-MRI) and Magnetic Resonance Spectroscopy (MRS) of Head and Neck Tumors

National Institutes of Health (NIH)

Memorial Sloan Kettering Cancer Center

radiotherapy

1. This is a phase II study of radiotherapy for patients with locally advanced HCC.
2. Patients whose tumor(s) are not suitable for other local treatment, such as surgery, trans-arterial chemoembolization (TAE), ethanol injection, or radiofrequency ablation. will be enrolled.
3. Radical radiotherapy will be started after pre-treatment evaluation. The total dose of RT will be 50Gy in 25 fractions to local tumor(s).
4. Dynamic contrast enhanced MRI and serum samples will be done at the following time points to assess the change in tumor perfusion: (1) before the start of thalidomide treatment; (2) 2weeks after radiotherapy begins; and (3) 1 month after radiotherapy completes. DCEMRI will then be done every 3 months until disease progression.
5. The study was designed to evaluate the response rate and tolerability of radical radiotherapy for locally advanced HCC. The sample size was determined by the expected incidence of grade 4 toxicity and response rate of radiotherapy for locally advanced HCC. Since the grade 4 toxicity of radiotherapy alone is 10%, the response rate is 60% we need at least 12 patients to evaluate for the treatment.

Hepatocellular carcinoma (HCC) is one of the most common malignancies in Asian countries. Surgical resection is potentially the only form of curative treatment. However, less than 20% of patients are surgical candidates at diagnosis. Nonsurgical treatment options include transcatheter arterial chemoembolization (TACE), percutaneous acetic acid or ethanol injection therapy and radio-frequency ablation. They are sometimes unsatisfactory, especially for patients with portal vein thrombosis or large infiltrative hepatic tumors. Repeated treatments are often necessary.

Radiotherapy (RT) for the treatment of HCC has been attempted for more than 4 decades. Early trials adopted whole liver irradiation but used an inadequate radiation dose. Because of the unsatisfactory results obtained with this low-dose whole liver irradiation, RT has not long been considered for the treatment of HCC. Recently, local, not whole, liver RT has been attempted by several investigators, who have shown that high doses of radiation can be safely delivered to a portion of the liver alone or in combination with other nonsurgical modalities. Their results suggest that local RT can be an effective component of the treatment regimen for HCC.

Development of surrogate markers to monitor the response of HCC to radiotherapy is important because of the following reasons. First, the response as evaluated by conventional imaging studies is usually slow and may be unreliable. The maximal response to radiotherapy is often achieved 6 months after completion of radiotherapy. The slow response to radiotherapy makes it difficult to modify an ineffective treatment regimen in a more timely fashion to HCC, especially for patients with low serum a-fetal protein (AFP). Second, intra-hepatic recurrence outside RT field is a common cause of RT treatment failure. Nearly half of the patients recur after RT with lesions outside RT fields. Inflammation and normal liver damage caused by RT may have deleterious effect on tumor control through the release of cytokines or angiogenic factors. Therefore, the biological consequence of RT in both the tumors and the non-tumor liver parenchyma shall be carefully evaluated.

Dynamic contrast enhanced magnetic resonance imaging (DCEMRI) may assess hepatic perfusion parameters which correlate with the severity of cirrhosis and portal hypertension. In cervical cancer, DCEMRI enables us to evaluate the microcirculation of tumors as well as the blood perfusion of normal parenchyma. Malignancy, stage and prognosis have all been correlated with the enhancement parameters in cervical, breast cancers.Several studies have shown that successful therapies also result in changes in DCEMRI parameters, which may prove to be a more accurate and earlier indication of response. De Vries et al reported, in rectal carcinoma patients receiving preoperative radiotherapy, that perfusion index showed a significant increase in the 1st and 2nd week of treatment. High perfusion index values correlated with greater lymph node down-staging. Moffat et al also reported increased apparent diffusion coefficient (ADC) 3 weeks after the initiation of RT in brain cancer patients who had better local response. Circulating angiogenic factors have been shown to provide important prognostic information about a variety of cancers (21). Elevated serum levels of VEGF or bFGF have been associated with increased invasiveness of HCC. Placental growth factor (PlGF), a homolog of VEGF, has been shown to have a synergistic effect with VEGF in pathologic angiogenesis, such as angiogenesis induced by cancer or ischemia, but its prognostic value in human cancers remains unclear.

We would like to correlate functional image studies of blood flow and serum cytokines during radiotherapy with treatment outcome in hepatocellular carcinoma patients.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Radiotherapy Plus Thalidomide in Locally Advanced Hepatocellular Carcinoma	NCT00155272	Hepatocellular ...	Thalidomide	20 Years - 70 Years	National Taiwan University Hospital
Metastatic Colorectal Cancer: Treatment Response With Dynamic Contrast MRI	NCT00820456	Colorectal Neop... Hepatic Neoplas...	DCE-MRI	18 Years -	American College of Radiology
Quantitative Imaging Biomarkers for Sarcoma	NCT02579980	Sarcoma	DCE and DWI MRI Surgery	18 Years -	Columbia University
Feasibility Study of Prostate Tumor Localization for Focal Cryoablation of Prostate Carcinoma	NCT00851682	Prostate Cancer	MRI scan	20 Years - 85 Years	Washington University School of Medicine
Dynamic Contrast Enhanced MRI (DCE-MRI) Diffusion Weighted MRI (DW-MRI) and Magnetic Resonance Spectroscopy (MRS) of Head and Neck Tumors	NCT00581906	Head and Neck C...	DCE-MRI, DW-MRI...	18 Years -	Memorial Sloan Kettering Cancer Center
Radiotherapy Plus Thalidomide in Locally Advanced Hepatocellular Carcinoma	NCT00155272	Hepatocellular ...	Thalidomide	20 Years - 70 Years	National Taiwan University Hospital
A Phase II Study of Radiotherapy for Locally Advanced Hepatocellular Carcinoma (HCC)	NCT00154817	Hepatocellular ...	radiotherapy	20 Years - 75 Years	National Taiwan University Hospital
Quantitative Imaging Biomarkers for Sarcoma	NCT02579980	Sarcoma	DCE and DWI MRI Surgery	18 Years -	Columbia University

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