Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Prostatic Neoplasms

Pancreatic Neoplasms

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Adenocarcinoma

Liver Neoplasms

Liver Diseases

Pancreatic Cancer

Hematinics

All Drugs and Chemicals

Liver Extracts

Patients undergo 3-Dimensional Ultrasound-Guided Radiation Therapy prior to and during radiation therapy. Patients also undergo kilo-voltage Cone-Beam Computed Tomography prior to radiation therapy.

Undergo kilo-voltage cone beam computed tomography

Cone-Beam Computed Tomography

Undergo ultrasound-guided radiation therapy

3-Dimensional Ultrasound-Guided Radiation Therapy

Ping Xia, PhD

Kevin Stephans, MD

This clinical trial studies if kilo-voltage cone beam computed tomography (KV-CBCT) and ultrasound imaging works in guiding radiation therapy in patients with prostate, liver, or pancreatic cancer. Computer systems, such as KV-CBCT and ultrasound imaging, allow doctors to create a 3-dimensional picture of the tumor may help in planning radiation therapy and may result in more tumor cells being killed.

PRIMARY OBJECTIVES:

I. To investigate the feasibility of combining on-board cone beam computed tomography (CBCT) with ultrasound imaging to overcome the shortcomings of CBCT or ultrasound imaging alone for imaging guided radiotherapy delivery.

OUTLINE:

Patients undergo ultrasound imaging prior to and during radiation therapy. Patients also undergo kilo-voltage cone beam computed tomography prior to radiation therapy.

Update (2021/02/04): Removed secondary outcome "Incidence of Adverse Events Related to the Ultrasound Probe". Per PI: Study initially intended to involve a non-FDA approved probe for use with liver patients but removed this section.

KV-CBCT and Ultrasound Imaging in Guiding Radiation Therapy in Patients With Prostate, Liver, or Pancreatic Cancer

Integrated 3D X-ray and Ultrasound Guided Radiation Therapy of Soft Tissue Targets

Percentage of ultrasound images which are clinically adequate for treatment set-up in the judgment of the treating physician

Proportion of participants able to have the ultrasound probe attached during the entire treatment course

Quality of plans for patients not affected in the presence of the ultrasound probe, defined as no more than a 2% decrease in tumor coverage, and also no more than a 2% increase in the dose to the most critical normal tissue for that tumor location

Case Comprehensive Cancer Center

No plan to collect adverse event data (per-protocol)

Patients undergo 3-Dimensional Ultrasound-Guided Radiation Therapy prior to and during radiation therapy. Patients also undergo kilo-voltage Cone-Beam Computed Tomography prior to radiation therapy.

Cone-Beam Computed Tomography: Undergo kilo-voltage cone beam computed tomography

3-Dimensional Ultrasound-Guided Radiation Therapy: Undergo ultrasound-guided radiation therapy

Diagnostic (KV-CBCT, Ultrasound-guided Radiation Therapy)

40-49 years

50-59 years

60-69 years

70-79 years

80-89 years

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Ping Xia

Participants undergo 3-Dimensional Ultrasound-Guided Radiation Therapy prior to and during radiation therapy. Participants also undergo kilo-voltage Cone-Beam Computed Tomography prior to radiation therapy.

Cone-Beam Computed Tomography: Undergo kilo-voltage cone beam computed tomography

3-Dimensional Ultrasound-Guided Radiation Therapy: Undergo ultrasound-guided radiation therapy

Percentage of Ultrasound Images Which Are Clinically Adequate for Treatment Set-up

Number of Participants Able to Have the Ultrasound Probe Attached During the Entire Treatment Course

Percent of Patients Whose Plan Quality Was Not Not Affected in the Presence of the Ultrasound Probe

Overall Study

Symptoms and General Pathology

Liver Cirrhosis

Hypoxia

Fibrosis

Anti-Infective Agents

Antineoplastic Agents

Misonidazole

Antiprotozoal Agents

Antiparasitic Agents

Patients undergo transcatheter arterial embolization. Patients also receive 18F-fluoromisonidazole IV and undergo PET/CT scans 4 weeks prior to embolization treatment and in the 20 hours following completion of treatment.

18F-Fluoromisonidazole

Undergo transcatheter arterial embolization

Arterial Embolization

Computed Tomography

Positron Emission Tomography

Rajesh Shah

This clinical trial studies how well 18F-fluoromisonidazole (\[18F\]FMISO) positron emission tomography (PET)/computed tomography (CT) works after transcatheter arterial embolization in imaging tumors in patients with liver cancer. Transcatheter arterial embolization blocks blood flow to tumor cells by inserting tiny foreign particles into an artery near the tumor. \[18F\]FMISO is a type of radioimaging agent that binds to large molecules in tumor cells that have a low level of oxygen, and the radiation given off by \[18F\]FMISO is picked up by a PET scan and this may help researchers learn whether changes occur in the tumors after treatment, which can help decide how well the treatment worked earlier than is currently possible

PRIMARY OBJECTIVES:

I. Determine the variability of 18F FMISO uptake in hepatocellular carcinoma (HCC) tumors compared to normal liver after transcatheter arterial embolization by determining the difference in the mean of the maximum standardized uptake value (SUVmax) and tumor-to-liver ratio (TLR) of a region of normal liver and of up to 5 index tumors.

SECONDARY OBJECTIVES:

I. Determine if areas of tumor recurrence as determined by CT or magnetic resonance imaging (MRI) within a 6 month period after transcatheter arterial embolization show evidence of increased 18F FMISO labeling on the initial post treatment 18F FMISO PET/CT.

II. Determine the variability in SUVmax and TLR of untreated (non embolized) HCC lesions compared to normal liver by determining the difference in the mean of the SUVmax and TLR of normal liver and tumor.

III. Determine any toxicities related to \[18F\]FMISO use for PET/CT.

OUTLINE:

Patients undergo transcatheter arterial embolization. Patients also receive 18F-fluoromisonidazole intravenously (IV) and undergo PET/CT scans within 4 weeks prior to embolization treatment and in the 20 hours following completion of treatment.

After completion of treatment, patients are followed up at 2 and 3 months.

[18F]FMISO PET/CT After Transcatheter Arterial Embolization in Imaging Tumors in Patients With Liver Cancer

Assessment of Treatment-Induced Tissue Hypoxia After Transcatheter Arterial Embolization of Hepatocellular Carcinoma: A Feasibility Study With [18F]FMISO PET/CT

All participants undergo transcatheter arterial embolization (TACE) and 18F-fluoromisonidazole (18F-FMISO) positron emission tomography (PET)/computed tomography (CT) scans were conducted. Maximum standardized uptake value (SUVmax) were determined at the tumor lesion and in normal tissue, represented by liver. The variability of 18F-FMISO uptake in hepatocellular carcinoma (HCC) tumors post-TACE was assessed as the ratio of the SUVmax as observed in the tumor vs liver (tumor-to-liver ratio, TLR). The outcome is reported as the mean TLR, with standard deviation.

Follow-up 18F-fluoromisonidazole (18F-FMISO) positron emission tomography (PET)/computed tomography (CT) scans were to be conducted within 6 months or at the time of tumor recurrence. Maximum standardized uptake value (SUVmax) were determined at the tumor lesion and in normal tissue, represented by liver. The variability of 18F-FMISO uptake at the hepatocellular carcinoma (HCC) tumor lesion site post-TACE was assessed as the mean difference in the ratio of the SUVmax as observed in the tumor vs liver (tumor-to-liver ratio, TLR), between lesions that recurred, and those that did not. The outcome is reported as the mean TLR, with standard deviation.

Toxicity to 18F-fluoromisonidazole (18F-FMISO) was assessed by the number of adverse events that occurred within 18 hours of administration (about 10 half-lives), that were also unanticipated and related to 18F-FMISO. The outcome is reported as the number of adverse events that were unanticipated and related to 18F-FMISO, a number without dispersion.

National Cancer Institute (NCI)

Stanford University

Patients undergo transcatheter arterial embolization. Patients also receive 18F-fluoromisonidazole IV and undergo PET/CT scans 4 weeks prior to embolization treatment and in the 20 hours following completion of treatment.

18F-Fluoromisonidazole: Undergo \[18F\] FMISO PET/CT

Arterial Embolization: Undergo transcatheter arterial embolization

Computed Tomography: Undergo \[18F\] FMISO PET/CT

Positron Emission Tomography: Undergo \[18F\] FMISO PET/CT

Diagnostic (18F-fluoromisonidazole, PET/CT, Embolization)

Age, Categorical

Age, Continuous

Before participants undergo transcatheter arterial embolization (TACE), ie, at baseline, 18F-fluoromisonidazole (18F-FMISO) positron emission tomography (PET)/computed tomography (CT) scans were conducted. Maximum standardized uptake value (SUVmax) were determined at the tumor lesion and in normal tissue, represented by liver. The variability of 18F-FMISO uptake in hepatocellular carcinoma (HCC) tumors before treatment was assessed as the ratio of the SUVmax as observed in the tumor vs liver (tumor-to-liver ratio, TLR). The data is reported as the mean TLR, with standard deviation.

Maximum Standardized Uptake Value (SUVmax) in Tumor vs Normal Tissue

Due to withdrawal, not all participants completed for this outcome.

Post-treatment Maximum Standardized Uptake Value (SUVmax) in Tumor and Normal Tissue

Follow-up 18F-fluoromisonidazole (18F-FMISO) positron emission tomography (PET) scans at the time of tumor recurrence were not conducted.

Maximum Standardized Uptake Value (SUVmax) at Lesion Sites With and Without Tumor Recurrence

All participants are included for this outcome.

Adverse Events Related to 18F-fluoromisonidazole (18F-FMISO)

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Breast Neoplasms

Melanoma

Head and Neck Neoplasms

Sarcoma

Lung Neoplasms

Ovarian Neoplasms

Kidney Neoplasms

Skin Diseases

Neoplasms, Connective and Soft Tissue

Breast Diseases

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Gonadal Disorders

Urologic Neoplasms

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Ovarian Cancer

Soft Tissue Sarcoma

Patients undergo B-WARM at 39 degrees C for 30 minutes.

Patients undergo B-WARM at 39 degrees C for 2 hours.

Hyperthermia Treatment

Laboratory Biomarker Analysis

Anurag Singh

This randomized pilot clinical trial studies body warming in improving blood flow and oxygen delivery to tumors in patients with cancer. Heating tumor cells to several degrees above normal body temperature may kill tumor cells.

PRIMARY OBJECTIVES:

I. To determine the feasibility and efficacy of 2 different Body Warming to Alter (Thermo) Regulation and the Microenvironment (B-WARM) regimens on altering tumor blood flow in patients with a variety of malignancies.

SECONDARY OBJECTIVES:

I. To determine if duration and thermal dose of B-WARM changes duration and extent of tumor blood flow changes in patients with a variety of malignancies.

OUTLINE: Patients are randomized to 1of 2 arms.

ARM I: Patients undergo B-WARM at 39 degrees Celsius (C) for 30 minutes.

ARM II: Patients undergo B-WARM at 39 degrees C for 2 hours.

After completion of study, patients are followed up at 30 days.

Body Warming in Improving Blood Flow and Oxygen Delivery to Tumors in Patients With Cancer

Body Warming to Alter [Thermo] Regulation and the Microenvironment [B-WARM] Therapy: A Pilot Study

The primary analysis will be implemented using an analysis-of-covariance model for both blood flow and blood volume.

The frequency of toxicities will be tabulated by grade across all dose levels and cycles. The frequency of toxicities will also be tabulated for the dose estimated to be the maximum tolerated dose.

Roswell Park Cancer Institute

Stomach Neoplasms

Frailty

Stomach Diseases

Stomach Cancer

Dermatologic Agents

Coal Tar

Keratolytic Agents

Patients undergo a physical therapy consultation and complete home exercises 3 days per week.

Best Practice

Exercise Intervention

Physical Therapy

Questionnaire Administration

Mark Rubinstein, PhD

This trial studies how well a prehabilitation program works to improve patient outcomes after surgery compared to the normal standard of care prehabilitation in frail patients undergoing surgery for pancreatic, liver, or gastric cancer. Frailty is defined as the pathophysiology of aging or through the accumulation of physiologic and functional deficits. Prehabilitation programs seek to optimize the medical and physical state of patients prior to undergoing surgery with the goal of improving outcomes following surgery. Despite evidence for its importance in health outcomes for frail patients, prehabilitation programs have not been well studied in cancer surgery populations. This trial may provide researchers with more information on how to improve patient outcomes after cancer surgery through the use of prehabilitation programs.

PRIMARY OBJECTIVES:

I. To develop a novel, multi-dimensional index of physiologic reserve and resilience specific to surgical cancer patients.

II. To implement and assess a novel comprehensive multidimensional prehabilitation program on frail cancer surgery patients.

OUTLINE: All patients enrolled (both frail and non-frail) will be randomized (1:1) at the time of enrollment to receive pre-operative exercise or non-preoperative exercises. Randomization will be stratified by frailty status.

ARM I: Enrolled patients undergo a physical therapy consultation and complete home exercises 3 days per week, in addition to standard guidelines.

ARM II: Enrolled patients follow standard guidelines.

All patients are followed up at 2 weeks after surgery and then every 3 months.

The RIOT Trial: Re-Defining Frailty and Improving Outcomes With Prehabilitation for Pancreatic, Liver, or Gastric Cancer

Re-Defining Frailty and Improving Outcomes Through Prehabilitation (RIOT Trial)

A rapid assessment for frailty using the widely used 5-item fatigue, resistance, ambulation, illness, \& loss of weight (FRAIL) questionnaire will be performed. Patients are identified as frail by scoring 2 or more points on the FRAIL questionnaire. The frailty assessment will be aimed at identifying factors related to the 6 characteristics of frailty: physical performance, gait speed, mobility, nutritional status, mental health and cognition.

Will be assessed using standardized case report forms.

Will be calculated using the Comprehensive Complication Index (CCI). This method is more powerful than standard binary measures of morbidity (presence/absence of individual events) as it presents a quantitative score based on an aggregate weighted total ranging from 0 (no complications) to 100 (death).

Will be recorded by administration of the Patient Reported Outcomes Measurement Information System (PROMIS) health-related quality of life questionnaire. PROMIS is a validated set of patient-centered measures that evaluates and monitors life domains (physical, mental, social health) and provide standardized patient reported outcome resources for use in clinical research and practice.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
KV-CBCT and Ultrasound Imaging in Guiding Radiation Therapy in Patients With Prostate, Liver, or Pancreatic Cancer	NCT02337465	Adult Liver Car... Malignant Pancr... Prostate Carcin...	Cone-Beam Compu... 3-Dimensional U...	19 Years -	Case Comprehensive Cancer Center
[18F]FMISO PET/CT After Transcatheter Arterial Embolization in Imaging Tumors in Patients With Liver Cancer	NCT02695628	Adult Liver Car... Liver Cirrhosis	18F-Fluoromison... Arterial Emboli... Computed Tomogr... Positron Emissi...	19 Years -	Stanford University
Body Warming in Improving Blood Flow and Oxygen Delivery to Tumors in Patients With Cancer	NCT01896778	Adult Liver Car... Breast Carcinom... Colon Carcinoma Kidney Neoplasm Lung Carcinoma Malignant Head ... Malignant Neopl... Melanoma Ovarian Neoplas... Soft Tissue Sar...	Hyperthermia Tr... Laboratory Biom...	18 Years -	Roswell Park Cancer Institute
The RIOT Trial: Re-Defining Frailty and Improving Outcomes With Prehabilitation for Pancreatic, Liver, or Gastric Cancer	NCT04602026	Adult Liver Car... Gastric Carcino... Malignant Solid... Pancreatic Carc...	Best Practice Exercise Interv... Physical Therap... Questionnaire A...	18 Years -	Ohio State University Comprehensive Cancer Center

Spots Global Cancer Trial Database for adult liver carcinoma