Neoplasms

Symptoms and General Pathology

All Conditions

Neoplastic Cells, Circulating

Neoplasm Metastasis

Neoplastic Processes

Tai-Horng Young

Yin-Tzu Chen

This culture system utilizes the special affinity difference of biomedical material coating for different cells to achieve the effect of isolating tumor cells from the blood sample. The coating of the system has the characteristic that to make the WBCs adhesion, but the cancer cells in the blood sample suspend in the culture medium, which achieves the effect of separating cancer cells from the blood. The supernatant with the cancer cells can further be isolated from the cultural system for related analysis and detection to achieve early diagnosis and screening.

Culture System for Isolating Circulating Tumor cells_2

Culture System for Isolating Circulating Tumor Cells

The number of circulating cancer cells from the blood sample will be investigated. To distinguish cancer cells from blood cells for the system, the lung cancer cells were immunofluorescence stained for Cytokeratin, white blood cells were stained for CD45 and nuclei were counterstained with DAPI.

The cell isolation efficiency was characterized by spiking A549 lung cancer cells with celltracker at the concentrations 1000, 100 and 10 cells into whole blood.

National Taiwan University Hospital

All Drugs and Chemicals

Fluorodeoxyglucose F18

Radiopharmaceuticals

Participants will undergo a PET/CT scan with radiolabel 18F-FDG.

Participants will undergo a PET/MRI scan with radiolabel 18F-FDG.

Participants will undergo a PET/CT scan with radiolabel 68Ga-DOTA-TATE.

Participants will undergo a PET/MRI scan with radiolabel 68Ga-DOTA-TATE.

Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging

F-18 FDG

Ga-68-DOTA-TATE

Scan using a regular medical care (IDE-exempt) Discovery 600 / 690 PET/CT scanner.

Positron Emission Tomography / Computed Tomography (PET/CT) Scan

Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Scan

Andrei Iagaru

This clinical trial studies how well positron emission tomography (PET)/computed tomography (CT) works compared to PET/magnetic resonance imaging (MRI) in evaluating patients with cancer. PET/CT and PET/MRI may determine which scanner is best for the patient's type of cancer and other types of cancers.

PRIMARY OBJECTIVES:

I. To evaluate if PET/CT and PET/MRI scanners provide equivalent results for evaluation of cancer patients.

OUTLINE:

Patients receive standard of care 18F-fludeoxyglucose (FDG) or Ga68-DOTA-TATE intravenously (IV). Within 45-60 minutes, patients then undergo PET/CT imaging immediately followed by PET/MRI. Each participant is to receive 18-FDG or 68Ga-DOTA-TATE only, no participant was to receive both radiotracers.

Comparison of PET/CT vs. PET/MRI Using 2 Radiopharmaceuticals

Comparison of PET/CT vs. PET/MRI

Standardized uptake value max (SUVmax) is a measurement of the maximum radiopharmaceutical uptake value within the region of interest (ROI). SUVmax is calculated as the ratio of activity concentration:injected dose/body weight. The outcome is reported as the mean SUVmax with standard deviation (SD), reported for 8 specific organs or bodily locations.

Standardized uptake value max (SUVmax) is a measurement of the maximum radiopharmaceutical uptake within the region of interest (ROI). Relative accuracy of a particular radiotracer in a particular tissue is determined by expressing the absolute accuracy (obtained in the primary outcome measure) in terms of percent difference between SUVmax values obtained from PET/CT and PET/MR.

Percentage difference is expressed as the difference of the means in SUVmax for the PET/CT and PET/MRI scan procedures for the particular radiotracer, divided by the mean between the values for the 2 scan procedures.

The closer the percent difference is to 0%, the better the agreement between the two scanners. The outcome is expressed as the percentage difference, a number without dispersion.

Stanford University

Associate Professor of Radiology

Per protocol, only unanticipated adverse events were to be collected.

Participants will undergo a PET/CT scan with radiolabel 18F-FDG.

F-18 FDG: Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging

Positron Emission Tomography / Computed Tomography (PET/CT) Scan: Scan using a regular medical care (IDE-exempt) Discovery 600 / 690 PET/CT scanner.

18F-FDG PET/CT Scan

Participants will undergo a PET/MRI scan with radiolabel 18F-FDG.

F-18 FDG: Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging

Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Scan: Scan using a NOVEL GE PET/MRI scanner.

18F-FDG PET/MRI Scan

Participants will undergo a PET/CT scan with radiolabel 68Ga-DOTA-TATE.

Ga-68-DOTA-TATE: Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging

Positron Emission Tomography / Computed Tomography (PET/CT) Scan: Scan using a regular medical care (IDE-exempt) Discovery 600 / 690 PET/CT scanner.

68Ga-DOTA-TATE PET/CT Scan

Participants will undergo a PET/MRI scan with radiolabel 68Ga-DOTA-TATE.

Ga-68-DOTA-TATE: Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging

Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Scan: Scan using a NOVEL GE PET/MRI scanner.

68Ga-DOTA-TATE PET/MRI Scan

Baseline information reflects participation of the individual human participants. Individual human participants are present in multiple assessment groups ("arms" or "cohorts"), and to avoid over-representation of those participants, data is not reported by group.

Total Participants

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Most subjects participated in more than 1 treatment arm. In order to not have participants represented multiple times in Participant Flow, this information is provided only at the study level.

Aortic arch

Gluteal muscle

Gluteal fat

Cerebellum

Parotid Gland

Lung

Liver

Spleen

Not all scans at all body locations could be completed.

Absolute Accuracy of SUV Max of PET/CT vs PET/MRI

PET/CT and PET/MRI scans were conducted using radiotracer 18-FDG.

18-FDG PET/CT and PET/MRI

PET/CT and PET/MRI scans were conducted using radiotracer 68Ga DOTA-TATE.

68Ga DOTA-TATE PET/CT and PET/MRI

PET/CT vs PET/MRI Difference in Standardized Uptake Value Max (SUVmax), by Radiotracer

Participant Flow reflects participation of individual human participants. Individual participants are present in multiple assessment groups ("arms" or "cohorts").

Total Participant Flow

Overall Study

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

MRI to ultrasound fusion guided prostate biopsy

SmartTarget - Biopsy

Hashim U Ahmed, FRCS PhD

The purpose of this study is to determine how well SmartTarget guided prostate biopsies perform, compared with our current standard of "visually directed biopsies" in the detection of prostate cancer.

The diagnosis of prostate cancer is dependent upon sampling the prostate to confirm disease. Standard trans-rectal biopsies are taken in a random fashion, without prior knowledge of the disease location. Transperineal mapping biopsies overcome this by systematically samples the entire gland but are very intensive and time consuming to perform.

An alternative method is to perform targeted prostate biopsies where an MRI prior to biopsy can be used to inform doctors about the location of the disease. This is a difficult procedure to perform as it requires the surgeon to mentally translate the location of disease on MRI image to the live ultrasound seen in theatre.

SmartTarget may help this procedure by providing guidance to the location of the disease by fusing the MRI image onto the live ultrasound, thereby providing the clinician a target to biopsy.

This trial will compare the outcomes of "visually directed biopsies" with those directed by SmartTarget

SmartTarget: BIOPSY

SmartTarget - A Magnetic Resonance Image to Ultrasound Fusion System for Targeted Prostate Intervention: Biopsy

The proportion of men with clinically significant disease based on SmartTarget guided biopsy compared to the proportion of men with clinically significant disease based on visually-directed biopsy.

The targeting efficiency of the SmartTarget guided biopsies versus visually-directed biopsies measured by:

Number of cores required to obtain the highest cancer risk category Number of cores with cancer Maximum Cancer Core Length and Total Cancer Core Length Highest Grade Cancer

To evaluate the clinical usability of SmartTarget guided biopsy as measured by:

Length of Procedure SmartTarget model generation time SmartTarget re-registration rate SmartTarget failure rate

To assess how this biopsy strategy impacts on quality of life as measured using validated questionnaires:

IPSS IIEF EQ5D - 5L

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Culture System for Isolating Circulating Tumor cells_2	NCT04125667	Early Diagnosis Diagnostic Tech...		20 Years - 70 Years	National Taiwan University Hospital
Comparison of PET/CT vs. PET/MRI Using 2 Radiopharmaceuticals	NCT03125629	Cancer Diagnosi... Diagnostic Tech... Diagnostic Imag...	F-18 FDG Ga-68-DOTA-TATE Positron Emissi... Positron Emissi...	18 Years -	Stanford University
Comparison of PET/CT vs. PET/MRI Using 2 Radiopharmaceuticals	NCT03125629	Cancer Diagnosi... Diagnostic Tech... Diagnostic Imag...	F-18 FDG Ga-68-DOTA-TATE Positron Emissi... Positron Emissi...	18 Years -	Stanford University
Culture System for Isolating Circulating Tumor cells_2	NCT04125667	Early Diagnosis Diagnostic Tech...		20 Years - 70 Years	National Taiwan University Hospital
Culture System for Isolating Circulating Tumor cells_2	NCT04125667	Early Diagnosis Diagnostic Tech...		20 Years - 70 Years	National Taiwan University Hospital
SmartTarget: BIOPSY	NCT02341677	Prostatic Neopl... Diagnostic Tech...	SmartTarget - B...	-	University College, London

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