Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Bile Duct Diseases

Liver Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Biliary Tract Diseases

Primary Liver Cancer

Hematinics

All Drugs and Chemicals

Anticoagulants

Micronutrients

Bone Density Conservation Agents

Liver Extracts

Edetic Acid

Pentetic Acid

Antidotes

Protective Agents

Chelating Agents

Iron

Iron Chelating Agents

Calcium

Calcium, Dietary

Patient receives each of these over one minute. For the gadoxetate disodium, dynamic imaging is performed immediately and imaging is performed at 20 minutes. For the gadobutrol, dynamic imaging is performed immediately.

Contrast-enhanced Magnetic Resonance Imaging

Gadobutrol

Gadoxetate Disodium

Janio Szklaruk, MD, PHD

This clinical trial studies contrast-enhanced magnetic resonance imaging (MRI) in detecting nonmalignant and malignant liver lesions. Diagnostic procedures, such as MRI, may help find and diagnose nonmalignant and malignant liver lesions. Contrast agents, such as gadoxetate disodium and gadobutrol, may help doctors to see MRI images more clearly.

PRIMARY OBJECTIVES:

I. To compare the specificity of contrast enhanced MRI using a liver specific agent Eovist (gadoxetate disodium) versus the combined use of Eovist and an intravascular-extracellular agent Gadavist (gadobutrol) for the radiologic detection and characterization of liver lesions via clinical stability and follow up imaging.

OUTLINE:

Patients receive gadoxetate disodium intravenously (IV) over 1 minute and undergo MRI. Patients then receive gadobutrol IV over 1 minute at the 20 minute mark during MRI.

Contrast-enhanced MRI in Detecting Benign and Malignant Liver Lesions

Radiologic Detection and Characterization of Benign and Malignant Liver Lesions in Contrast-Enhanced MRI

Summary statistics of sensitivity, specificity, true positives, true negatives, false positives, and false negatives will be provided for gadoxetate disodium and gadoxetate disodium + gadobutrol method. Accuracy, sensitivity, specificity, positive predictive value, and negative predictive value will be estimated along with corresponding 95% confidence intervals for the two methods. Comparison between the two methods will be made following method by Obuchowski. Other statistical analyses will be carried out as appropriate.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

All participants receive both Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans

Computed Tomography (CT)

Positron Emission Tomography (PET)

90-Yttrium (Y-90) Glass Microspheres

Technetium 99mTc albumin aggregated (99mTc-MAA)

Single-photon emission computerized tomography (SPECT) scan

Andrei Iagaru

This clinical trial studies how well yttrium-90 (Y90) glass microspheres positron emission tomography (PET)/computed tomography (CT) works in imaging patients with liver tumors . Images produced by PET/CT may provide better information about the distribution of particles, such as Y90 glass microspheres, delivered for selective internal radiation therapy (SIRT) as compared to regular medical care images useing technetium Tc-99m albumin-aggregated single photon emission computed tomography (SPECT)/CT images.

PRIMARY OBJECTIVES:

I. To evaluate the image quality of yttrium-90 (Y90) microspheres PET/CT post SIRT images as compared to technetium Tc-99m albumin aggregated (99mTc MAA) SPECT/CT.

SECONDARY OBJECTIVES:

I. To determine the superior accuracy in both distribution and dosimetry of Y90 PET/CT post-SIRT imaging compared to 99mTc MAA planar and SPECT/CT imaging.

OUTLINE:

Immediately after standard of care SIRT, patients receive Y90 glass microspheres and undergo PET/CT over 30 minutes.

This study compares the experimental images to the regular medical care images in the same participant.

Yttrium-90 (Y90) Glass Microspheres PET/CT in Imaging Patients With Liver Tumors

High Quality Imaging and Dosimetry of Yttrium-90 (90Y) SIRT Using a Digital PET/CT

Image quality for 90Y PET/CT scan images was assessed relative to the expected image quality of Standard of Care (SoC) 99mTc-MAA SPECT/CT scans obtained from the same participant. Assessments were conducted at 5, 10, 15 and 20 minutes after infusion. Scans were assessed on a 1 to 5 Likert scale by 2 Nuclear Medicine physicians who were blinded to patient information. The Likert scale for image quality was established as follows:

1. = Non-diagnostic
2. = Suboptimal
3. = Acceptable
4. = Good
5. = Excellent, equivalent to a SoC 99mTc-MAA SPECT/CT scan The scans for each individual participant at each timepoint was scored on the Likert scale, as determined by the 2 Nuclear Medicine physicians. The outcome is reported as the overall mean of the physician determinations for each time point, with standard deviation.

Radiopharmaceutical dosimetry was assessed based on the numerical tumor-absorbed dose value in Gray as calculated by SurePlan (MIM Software Inc, Cleveland, Ohio). The outcome is reported as the median tumor-absorbed dose in Gray for each scan method (90Y PET/CT and 99mTc-MAA SPECT/CT), with standard deviation.

Stanford University

Professor of Radiology (Nuclear Medicine)

All participants receive both Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans

* Computed Tomography (CT): As part of PET/CT and SPECT/CT scans.
* Positron Emission Tomography (PET): As part of PET/CT scan
* Single-photon emission computerized tomography (SPECT) scan: As part of SPECT/CT scan
* 90-Yttrium (Y-90) Glass Microspheres: Radiolabel for PET/CT scan
* Technetium 99mTc albumin aggregated (99mTc-MAA): Radiolabel for 99mTc-MAA SPECT/CT Scan

Yttrium Y-90 PET/CT vs 99mTc-MAA SPECT/CT Scans

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Andrei Iagaru, PROFESSOR OF RADIOLOGY (NUCLEAR MEDICINE)

5 minutes

10 minutes

15 minutes

20 minutes

Image Quality for 90-Y PET/CT Scans

All participants receive Y-90 PET/CT Scan

Computed Tomography (CT): As part of PET/CT scan. Positron Emission Tomography (PET): As part of PET/CT scan

90-Yttrium (Y-90) Glass Microspheres: Radiolabel for PET/CT scan

Yttrium Y-90 PET/CT

All participants receive 99mTc-MAA SPECT/CT scan

Computed Tomography (CT): As part of SPECT/CT scans. Single-photon emission computerized tomography (SPECT) scan: As part of SPECT/CT scan

Technetium 99mTc albumin aggregated (99mTc-MAA): Radiolabel for 99mTc-MAA SPECT/CT Scan

99mTc-MAA SPECT/CT Scans

Radiopharmaceutical Dosimetry Accuracy for 90-Y PET/CT Scans and 99mTc-MAA SPECT/CT Scans

Overall Study

Symptoms and General Pathology

Hernia

Incisional Hernia

Bile Duct Neoplasms

Pathological Conditions, Anatomical

Postoperative Complications

Biliary Tract Neoplasms

Patients undergo hepatectomy as planned using small bites fascial method for abdominal wall closure.

Patients undergo hepatectomy as planned using conventional fascial method for abdominal wall closure.

Quality-of-Life Assessment

Undergo hepatectomy using small bites fascial method for abdominal wall closure

Surgical Procedure

Undergo hepatectomy using conventional fascial method for abdominal wall closure

Timothy E Newhook, MD

Timothy E. Newhook

This clinical trial compares two different kinds of surgical closing techniques, short stitch suture or traditional suture, in patients who are having liver tumor surgery. This study may help researchers learn if one technique can lower the chances of developing a hole in the wall of the abdomen (an abdominal hernia) at the incision site better than the other.

PRIMARY OBJECTIVE:

I. To assess whether small bites abdominal wall closure reduces the risk of developing incisional hernia following liver surgery.

SECONDARY OBJECTIVES:

I. To compare short-term perioperative outcomes between small bites and typical fascial closure technique.

II. To assess the hernia incidence rate of short stich versus (vs.) standard closure in subgroups of patients with inverted-L or midline incisions.

III. To assess the hernia incidence rate of Kawaguchi-Gayet hepatectomy complexity classifications I/II vs. III (hernia rate by extent of hepatectomy).

IV. To assess the hernia incidence rate of preoperative chemotherapy or no preoperative chemotherapy (hernia rate by exposure to preoperative chemotherapy).

V. To assess impact of small bites abdominal wall closure on health care quality of life following liver surgery.

VI. To assess safety of small tissue bites fascial closure suture technique versus conventional fascial closure following hepatectomy.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (INTERVENTION): Patients undergo hepatectomy as planned using small bites fascial method for abdominal wall closure.

ARM II (CONTROL): Patients undergo hepatectomy as planned using conventional fascial method for abdominal wall closure.

After completion of study, patients are followed up at 1-4 weeks, and then at 3, 6, and 12 months.

Short Stitch Versus Traditional Suture for the Prevention of Incisional Hernia After Open Hepatectomy

Incisional Hernia Prevention After Open Hepatectomy by Small Tissue Bite Fascial Closure: A Randomized Clinical Trial

Definition of incisional hernia will be based on the European Hernia Society: Any abdominal wall gap with or without a bulge in the area of a postoperative scar perceptible or palpable by clinical examination or imaging. Assessment of the primary outcome will occur at 3, 6, and 12 months with a computed tomography scan/magnetic resonance imaging. Scans will be read and assessed for incisional hernia by 3 independent assessors blinded to the allocation. A correlation coefficient will be determined for their assessments. The cumulative incidence rate of incisional hernia at 12 months will be estimated, along with the 95% confidence interval.

Post-operative infection, complication or pain will be assessed using Chi-squared test or Fisher's exact test.

Will be compared between the two arms using two-sample t-test or Wilcoxon rank sum test.

Will use linear mixed effect modeling to assess the effects of time, arm as well as the interaction between arm and time.

Will be summarized using descriptive statistics (frequency, percentage) by arm, AE type, severity and attribution.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Contrast-enhanced MRI in Detecting Benign and Malignant Liver Lesions	NCT02156739	Hepatocellular ... Liver and Intra... Metastatic Mali... Primary Maligna...	Contrast-enhanc... Gadobutrol Gadoxetate Diso...	18 Years -	M.D. Anderson Cancer Center
Yttrium-90 (Y90) Glass Microspheres PET/CT in Imaging Patients With Liver Tumors	NCT03109262	Primary Maligna...	Computed Tomogr... Positron Emissi... 90-Yttrium (Y-9... Technetium 99mT... Single-photon e...	18 Years -	Stanford University
Short Stitch Versus Traditional Suture for the Prevention of Incisional Hernia After Open Hepatectomy	NCT04982653	Liver and Intra... Metastatic Mali... Primary Maligna...	Quality-of-Life... Surgical Proced... Surgical Proced...	18 Years -	M.D. Anderson Cancer Center
Contrast-enhanced MRI in Detecting Benign and Malignant Liver Lesions	NCT02156739	Hepatocellular ... Liver and Intra... Metastatic Mali... Primary Maligna...	Contrast-enhanc... Gadobutrol Gadoxetate Diso...	18 Years -	M.D. Anderson Cancer Center
Contrast-enhanced MRI in Detecting Benign and Malignant Liver Lesions	NCT02156739	Hepatocellular ... Liver and Intra... Metastatic Mali... Primary Maligna...	Contrast-enhanc... Gadobutrol Gadoxetate Diso...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for primary malignant liver neoplasm