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

Skin and Connective Tissue Diseases

Colorectal Neoplasms

Breast Neoplasms

Breast Diseases

Skin Diseases

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Fluorides

Fluoroazomycin arabinoside

Radiopharmaceuticals

Patients receive 18F-fluoroazomycin arabinoside IV and after 60 minutes undergo 5 PET-CT scans at 60, 90, 120, 150, and 180 minutes on days 1 and 2.

Patients receive 18F-fluoroazomycin arabinoside IV and after 60 minutes undergo 5 or less PET-CT scans on day 1 and 5 or less PET-CT scans \>= 24 hours later up to 10 days.

Computed Tomography

Fluorine F 18-fluoroazomycin Arabinoside

Positron Emission Tomography

Franklin C Wong

This early phase I trial studies how well 18F-fluoroazomycin arabinoside positron emission tomography (PET)-computed tomography (CT) works in diagnosing solid tumors. Using 18F-fluoroazomycin arabinoside with PET-CT may help doctors plan better treatment for patients with solid tumors. 18F-fluoroazomycin arabinoside may help to show how much oxygen is present in a tumor during a PET-CT scan.

PRIMARY OBJECTIVES:

I. To evaluate the feasibility of PET-CT using 18F-fluoroazomycin arabinoside (\[18F\]FAZA) and to determine the optimal imaging time to detect hypoxia in solid tumors.

SECONDARY OBJECTIVES:

I. To determine the variability of imaging findings from repeated \[18F\]FAZA PET-CT studies over \>= 24 hours up to 10 days.

II. To confirm the safety of \[18F\]FAZA administered during PET-CT imaging of hypoxia of solid tumors.

OUTLINE: Patients are assigned to 1 of 2 groups.

GROUP A: Patients receive 18F-fluoroazomycin arabinoside intravenously (IV) and after 60 minutes undergo 5 PET-CT scans at 60, 90, 120, 150, and 180 minutes on days 1 and 2.

GROUP B: Patients receive 18F-fluoroazomycin arabinoside IV and after 60 minutes undergo 5 or less PET-CT scans on day 1 and 5 or less PET-CT scans \>= 24 hours later up to 10 days.

After completion of study treatment, patients are followed up at 24 hours and at 30 days.

18F-Fluoroazomycin Arabinoside PET-CT in Diagnosing Solid Tumors in Patients

Test-Retest of (18)F-Fluoroazomycin Arabinoside ([18F]FAZA) PET-CT of Solid Tumors

Summary statistics of tumor volume, SUV, TMR, HTV1, HTV2, TLH1, TLH2, and their changes from baseline to later time point will be provided in mean, standard deviation, and range by time point. Lin's concordance correlation coefficient for these parameters will be calculated and MDC95 will also be calculated for 2 hour timepoint or other time points. Other statistical analyses will be carried out as appropriate.

Adverse events and vital signs will be monitored and described with descriptive statistics.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Infections

Symptoms and General Pathology

Communicable Diseases

Surgical Wound Infection

Patients undergo the collection of bile samples during standard of care surgery. Samples undergo routine laboratory testing.

Patients undergo the collection of bile samples during standard of care surgery. Samples undergo nanopore sequencing and routine laboratory testing.

Biospecimen Collection

Laboratory Procedure

Nanopore Sequencing

Nicholas D Chia

This early phase I trial evaluates nanopore sequencing for its ability to detect bacteria in bile and prevent surgical site infections in patients undergoing surgery for benign or malignant pancreatic tumors. Surgical site infections are a significant source of poor outcomes in patients undergoing surgery for pancreatic tumors. In most patients who develop this kind of infection, the bacteria identified as causing the infection is also frequently found to be in the bile at time of surgery. Using nanopore sequencing to detect bacteria in the bile of patients undergoing surgery may allow doctors to prevent surgical site infections or treat them sooner or more effectively.

PRIMARY OBJECTIVE:

I. To improve antibiotic stewardship (reducing duration of peri-operative prophylactic antibiotic regimen, reducing administration of broad-spectrum antibiotic) by providing surgical team with rapid Oxford Nanopore (ONT) sequencing data in the early post-operative setting.

SECONDARY OBJECTIVE:

I. To reduce the cost of care through reduction in surgical site infection (SSI) and improved antibiotic stewardship.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo the collection of bile samples during standard of care surgery. Samples undergo routine laboratory testing.

ARM II: Patients undergo the collection of bile samples during standard of care surgery. Samples undergo nanopore sequencing and routine laboratory testing.

After completion of study, patients' medical records are reviewed for 30 days.

"Answers in Hours" A Randomized Controlled Trial Using Microbiome Metagenomics for Bile Duct Cultures

Nanopore Sequencing for Detecting Bacteria in Bile and Preventing Surgical Site Infections in Patients Undergoing Surgery for Benign or Malignant Pancreatic Tumors

For continuous variables, t-test will be performed and for binary variables chi-square or fisher's exact testing will be performed as appropriate. Additional analysis will be performed as necessary to determine differences in study arms.

Mayo Clinic

Diseases and Abnormalities at or Before Birth

Heart and Blood Diseases

Blood and Lymph Conditions

Infarction

Hernia, Hiatal

Hernia

Ulcer

Hernias, Diaphragmatic, Congenital

Hernia, Diaphragmatic

Cholecystitis

Acalculous Cholecystitis

Choledocholithiasis

Splenomegaly

Duodenal Ulcer

Splenic Infarction

Ischemia

Necrosis

Pathological Conditions, Anatomical

Gallbladder Diseases

Biliary Tract Diseases

Internal Hernia

Hernia, Abdominal

Congenital Abnormalities

Bile Duct Diseases

Common Bile Duct Diseases

Gallstones

Cholelithiasis

Cholecystolithiasis

Peptic Ulcer

Duodenal Diseases

Stomach Diseases

Hypertrophy

Vascular Diseases

Lymphatic Diseases

Congenital Diaphragmatic Hernia

Postoperative Volume oriented incentive spirometry 3 times a day

Postoperative Flow oriented incentive spirometry 3 times a day

3 sets of 5 repeated deep breaths using volume oriented incentive spirometry 3 times a day for 2 days

Volume-oriented incentive spirometry

3 sets of 5 repeated deep breaths using flow oriented incentive spirometry 3 times a day for 2 days

Flow-oriented incentive spirometry

Abeer Fatima, MSPT-CPPT

To compare the effects of volume-oriented versus flow-oriented incentive spirometry on pulmonary function tests and functional capacity in patients of upper abdominal laparoscopic surgery. Previous studies were designed to target only spirometer without focusing on its different types and their effects. This study covers the research gap and therefore is designed to observe effects of different types of spirometer on pulmonary function of patients undergoing upper abdominal laparoscopic surgery.

The volume oriented incentive spirometer enables the patient to inhale air through a mouthpiece and corrugated tubing which is attached to a plastic bellows. The volume of air displaced is indicated on a scale located on the device enclosure. After the patient has achieved the maximum volume, the individual is instructed to hold this volume constant for 3 to 5 seconds.

Studies suggest a physiologically significant difference in the effect of the flow- and volume-oriented incentive spirometer. Flow-oriented devices enforce more work of breathing and increase muscular activity of the upper chest. Volume-oriented devices enforce less work of breathing and improve diaphragmatic activity.

Research was carried out a study on two experimental groups of patients in order to evaluate the effects of aerobic exercise training and incentive spirometry in controlling pulmonary complications following laparoscopic cholecystectomy, results indicated a significant reduction in heart rate, Oxygen Saturation of hemoglobin (SaO2), and inspiratory capacity for both groups. The researchers concluded that aerobic exercise and incentive spirometry were beneficial in reducing the postoperative pulmonary complications after laparoscopic cholecystectomy.

Another study observed the comparative study on the effect of preoperative and postoperative incentive spirometry on the pulmonary function of fifty patients who had undergone laparoscopic cholecystectomy. The authors concluded that pulmonary function is well-preserved with preoperative than postoperative incentive spirometry.

Another study observed that the volume incentive spirometry resulted in early recovery of both pulmonary function and diaphragm movement in patients who undergone laparoscopic abdominal surgery.

Incentive Spirometry and Upper Abdominal Laparoscopic Surgery

Compare the Effects of Volume-oriented Versus Flow-oriented Incentive Spirometry on Pulmonary Function and Functional Capacity in Patients of Upper Abdominal Laparoscopic Surgery

The six-minute walk test (6MWT) is a submaximal exercise test for evaluating physical functional capacity. Six meter walk distance ranges from 400 to 700 meter in normal individuals

Changes from the baseline will be measured on daily basis. Pulmonary function test will be measured by using a digital spirometer. Spirometry assesses the integrated mechanical function of the lung, chest wall, respiratory muscles, and airways by measuring the total volume of air exhaled from a full lung total lung capacity \[TLC\] TLC has a normal value ranges from 80% to 120%, of the predicted ratio.

Changes from the baseline will be measured on daily basis. Pulmonary function test will be measured by using a digital spirometer. FVC is the total volume of air that can be exhaled during a maximally forced expiration effort. It ranges from 80% to 120% of the predicted value.

FEV1 is the volume of air that can forcibly be blown out in the first 1 second, after full inspiration. Average values for FEV1 in healthy people depend mainly on sex and age. Values of between 80% and 120% of the average value are considered normal.

FEEV1/FVC is the ratio of FEV1 to FVC. In healthy adults, this should be approximately 70-80%

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-Fluoroazomycin Arabinoside PET-CT in Diagnosing Solid Tumors in Patients	NCT03168737	Malignant Breas... Malignant Color... Malignant Pancr... Malignant Solid...	Computed Tomogr... Fluorine F 18-f... Positron Emissi...	18 Years -	M.D. Anderson Cancer Center
"Answers in Hours" A Randomized Controlled Trial Using Microbiome Metagenomics for Bile Duct Cultures	NCT05523154	Benign Pancreat... Malignant Pancr...	Biospecimen Col... Laboratory Proc... Nanopore Sequen...	18 Years -	Mayo Clinic
18F-Fluoroazomycin Arabinoside PET-CT in Diagnosing Solid Tumors in Patients	NCT03168737	Malignant Breas... Malignant Color... Malignant Pancr... Malignant Solid...	Computed Tomogr... Fluorine F 18-f... Positron Emissi...	18 Years -	M.D. Anderson Cancer Center
Incentive Spirometry and Upper Abdominal Laparoscopic Surgery	NCT04716166	Cholecystitis Perforated Duod... Diaphragmatic H... Benign Pancreas... Malignant Pancr... Splenic Infarct... Splenomegaly Choledocholithi... Hiatal Hernia	Volume-oriented... Flow-oriented i...	25 Years - 65 Years	Riphah International University

Spots Global Cancer Trial Database for malignant pancreatic neoplasm