Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Anticoagulants

All Drugs and Chemicals

Micronutrients

Edetic Acid

Pentetic Acid

Antidotes

Protective Agents

Chelating Agents

Iron

Iron Chelating Agents

Patients receive gadodiamide IV and undergo a diagnostic multiparametric endorectal MRI. Patients with lesions visible on the diagnostic multiparametric endorectal MRI undergo transrectal MRI-guided biopsy within 2 weeks of diagnostic multiparametric endorectal MRI. Patients then undergo TRUS-guided biopsy per standard clinical care approximately 2 weeks after transrectal MRI-guided biopsy.

Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast

3 Tesla Magnetic Resonance Imaging

Gadodiamide

Multiparametric Magnetic Resonance Imaging

Transrectal Biopsy

Ultrasound-Guided Prostate Biopsy

Fergus Coakley

This pilot clinical trial studies transrectal magnetic resonance imaging (MRI)-guided biopsy to see how well it works in identifying cancer in patients with suspected prostate cancer who are scheduled to undergo standard biopsy. Transrectal MRI-guided biopsy uses a thin needle inserted through the rectum into the prostate and takes a sample of tissue, guided by MRI. MRI uses magnets to take pictures of the prostate and may be able to identify cancer. Transrectal MRI-guided biopsy may be more accurate and cause patients less pain than standard ultrasound-guided biopsy. It is not yet known whether transrectal MRI-guided biopsy is more effective than ultrasound-guided biopsy in identifying prostate cancer.

PRIMARY OBJECTIVES:

I. To improve the treatment of patients with prostate cancer utilizing diagnostic multi-parametric magnetic resonance imaging (MRI) and MRI-guided prostate biopsy combined with molecular and clinical data to help determine the extent of prostate cancer and risk of disease progression.

II. To determine the relative accuracy of transrectal MRI-guided versus ultrasound-guided biopsy for the diagnosis of prostate cancer in patients with an appropriate dominant target lesion at multiparametric MRI, using pooled cancer diagnoses by either MRI-guided or ultrasound-guided biopsy as the reference standard.

III. To determine the proportion of positive transrectal MRI-guided biopsies that demonstrate a higher Gleason score than contemporaneous transrectal ultrasound guided biopsy.

IV. To determine the management impact of transrectal MRI-targeted biopsy results as compared to transrectal ultrasound (TRUS)-guided systematic biopsy results.

OUTLINE:

Patients receive gadodiamide intravenously (IV) and undergo a diagnostic multiparametric endorectal MRI. Patients with lesions visible on the diagnostic multiparametric endorectal MRI undergo transrectal MRI-guided biopsy within 2 weeks of diagnostic multiparametric endorectal MRI. Patients then undergo TRUS-guided biopsy per standard clinical care approximately 2 weeks after transrectal MRI-guided biopsy.

Transrectal MRI-Guided Biopsy in Identifying Cancer in Patients With Suspected Prostate Cancer

Pilot Study of Transrectal Multiparametric MRI-Guided Biopsy: Role in Prostate Cancer Evaluation

The proportion of MRI-guided biopsies that demonstrate a higher Gleason score than contemporaneous TRUS guided biopsy for all patients diagnosed of prostate cancer based on the reference standard will be estimated. McNemar's test will be used to assess whether the MRI-guided biopsies are more likely to yield a higher Gleason score compared with TRUS guided biopsy. Simple logistic regression model will be used to assess the association between the higher Gleason score and patient characteristics and/or clinical information for patients diagnosed of prostate cancer.

The presence of cancer on either biopsy or absence of cancer on both will be used as the reference standard. For comparison of the two methods, the 2X2 matched sample tables will be presented, and the difference in sensitivity estimated. The relative accuracy of MRI- versus TRUS-guided biopsy will be compared using McNemar's test. To explore potential associations between the accuracy of each method with patient characteristics and/or clinical information, a binary endpoint will be created to reflect agreement between each method and the reference standard.

Medical Research Foundation, Oregon

National Cancer Institute (NCI)

OHSU Knight Cancer Institute

Professor and Chair

Patients receive gadodiamide IV and undergo a diagnostic multiparametric endorectal MRI. Patients with lesions visible on the diagnostic multiparametric endorectal MRI undergo transrectal MRI-guided biopsy within 2 weeks of diagnostic multiparametric endorectal MRI. Patients then undergo TRUS-guided biopsy per standard clinical care approximately 2 weeks after transrectal MRI-guided biopsy.

3 Tesla Magnetic Resonance Imaging: Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast

Gadodiamide: Given IV

Multiparametric Magnetic Resonance Imaging: Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast

Transrectal Biopsy: Undergo transrectal MRI-guided biopsy

Ultrasound-Guided Prostate Biopsy: Undergo TRUS-guided biopsy

Diagnostic (MRI, MRI-guided Biopsy, TRUS-guided Biopsy)

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Since recruitment was very low and funding did not materialize, the study was closed early and insufficient data was collected to analyze and report the outcomes.

Fegus Coakley

Due to low enrollment, insufficient data was collected to report this outcome

Proportion of MRI-guided Biopsies That Demonstrate a Higher Gleason Score Than Contemporaneous TRUS Guided Biopsy

Sensitivity of MRI-guided Biopsy

Sensitivity of TRUS-guided Biopsy

Overall Study

Skin and Connective Tissue Diseases

Digestive System Diseases

Rare Diseases

Breast Neoplasms

Carcinoma, Hepatocellular

Neuroendocrine Tumors

Neuroendocrine Tumor

Gastrointestinal Agents

Pancrelipase

Pancreatin

Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate

Adult participants, who were scheduled for repeated enhanced magnetic resonance imaging (MRI), receive a linear gadoliniumbased contrast agent (GBCA, i.e. Eovist/ Primovist, MultiHance or Omniscan) prior to MRI. Each participant will receive the same GBCA throughout the study.

Adult participants, who were scheduled for repeated enhanced magnetic resonance imaging (MRI), receive a macrocyclic gadolinium-based contrast agent (GBCA, i.e. Gadavist/ Gadovist, Dotarem, Magnescope or ProHance) prior to MRI. Each participant will receive the same GBCA throughout the study.

Adult participants who were never exposed to any gadolinium-based contrast agent and matching the population characteristics of the two GBCA arms. They will not receive any gadolinium-based contrast agent over the study course, but may undergo clinically indicated imaging (e.g. unenhanced magnetic resonance imaging (MRI), unenhanced or enhanced computed tomography, ultrasound and/or X-ray).

Motor Tests

Cognitive Tests

The UE-MRI of the brain will be performed at baseline and at the year 5 visit in order to exclude presence of a significant MRI abnormality

Unenhanced-MRI of the brain

Blood samples and spontaneous urine specimens will be collected through the course of the study to measure Gd concentration

Gadolinium Measurements

Administered as defined by the treating physician as part of routine clinical practice

Gadoxetate disodium

Gadobenate dimeglumine

Gadoterate meglumine

Gadobutrol

Gadoteridol

Nathalie LE FUR, PhD

Frantz HEBERT

Ronald Korn, MD

Valentine Mildred

Carla Harmath, MD

Teresa Osmulski

Praveen Sudhindra, MD

Mukesh Harisinghani, MD

Fishman Michael, MD

Joseph Yap

Leo Tsai, MD

Ricardo Sanchez, MD

Sara Schiller

Boris Nicolas Bloch, MD

Lauren Burke, MD

Rebecca Jordan

Nabeel SARWANI, MD

Meera Kasireddy

Ryan Lee, MD

Sydney Haldeman Sydney

Takeshi Yokoo, MD

Riya Nellippallil

Khaled Elsayes, MD

Nolan Caroll

Bruce Richard, MD

Patricia Moura

Joilda Batista de Almeida Rego, MD

Keyla Deucher

Cassiano Mateus Forcelini, MD

Brenda Santos

Ivan Pedrollo, MD

Marcela Maria Dutra

Israel Silva Maia, MD

Nicole Rabello

Luis Eduardo Werneck de Carvalho, MD

Luciana Cubas Volpe

Kathia Abdalla

Study Coordinator

Lis Gomes, MD

Gilberto Szarf

Ronaldo Baroni, MD

Samir Chenaf

Sebastien MOLIERE, MD

Alfonso Cerase, MD

Anna Ianza

Alessandra Guglielmi, MD

YoungJi Lee

Dong Joon Kim, MD

Hwasong Lee

Sang Soo Shin, MD

JinSil Choi

Won Chang, MD

Hayun Jung

Hae Woong Jeong, MD

Yun Jung

Jeong Heo, MD

Gyu Won Kim

JuYeon Cho,, MD

so hyun Kim

Joon Jeong, MD

DaJeong Kwon

Chang-hwan Choi, MD

This study is a postmarketing requirement jointly carried out by four NDA holders (Bayer AG, Bracco, GE Healthcare and Guerbet) and the CRO IQVIA.

The study aims to create detailed images of the organs and tissue of the human body during x-ray, CT-scan or MRI investigations, doctors are using contrast media (a kind of dye) which can be given to patients by injection into a blood vessel or by mouth.

In this study researchers want to find out whether so called gadolinium-based contrast agents (GBCAs) have an effect on body movement and mental skills when given to participants multiple times within 5 years.

The study plans to enroll about 2076 participants suffering from a condition for which they are likely to have at least annually a MRI or another imaging examinations. Only adults up to 65 years will be considered to join this study. During the study duration of 5 years participants will receive annually a MRI or other imaging tests (such as CT-scan, x-ray) and will visit the study doctor at least 7 times for physical examinations, laboratory investigations and tests on body movement and mental skills.

The primary objective of the study is to assess the potential effect of repeated exposure to either a linear or a macrocyclic gadolinium-based contrast agent (GBCA) on change from baseline to Year 5 in composite measure of motor and cognitive function among neurologically normal adults in comparison to a matched non-GBCA- exposed control group.

The secondary objectives comprise the assessment of the following endpoints in GBCA-exposed participants as compared to controls a) changes from baseline in composite measure of motor and cognitive function post-baseline on yearly basis (Years 1 to 4); b) changes from baseline in each individual test of motor and cognitive function on yearly basis (Years 1 to 5). Total Gd concentrations in blood and urine samples on yearly basis (Years 1 to 5) and adverse events will be collected as secondary objectives.

Of note : The study is considered interventional because of the addition of UE-MRI scans for all participants, as well as blood sampling and the administration of the motor and cognitive tests. The GBCA administered as part of the contrast-enhanced MR imaging in the experimental arms is not the intervention in this study. Neither the protocol nor the investigators assign patients to a specific GBCA as part of the study, making this part of the study observational rather than interventional. The participants were already scheduled, prior to study screening, to undergo CE-MRI as part of their clinical care. The choice of GBCA for the CE-MRI will be based on medical need and institutional usage of GBCA, independent of study participation.

Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years

Prospective Evaluation of Potential Effects of Repeated Gadolinium-based Contrast Agent (GBCA) Administrations of the Same GBCA on Motor and Cognitive Functions in Neurologically Normal Adults in Comparison to a Non-GBCA Exposed Control Group

The endpoint is a composite z score, defined as the weighted sum of the z scores of the individual tests

Bayer AG (Sponsor)

Bracco (Sponsor)

GEHC (Sponsor)

Guerbet

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Transrectal MRI-Guided Biopsy in Identifying Cancer in Patients With Suspected Prostate Cancer	NCT02501759	Health Status U... Prostate Carcin...	3 Tesla Magneti... Gadodiamide Multiparametric... Transrectal Bio... Ultrasound-Guid...	-	OHSU Knight Cancer Institute
Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years	NCT04373564	Motor Function Cognitive Funct... Contrast Media	Motor Tests Cognitive Tests Unenhanced-MRI ... Gadolinium Meas... Gadoxetate diso... Gadobenate dime... Gadodiamide Gadoterate megl... Gadobutrol Gadoteridol	18 Years - 64 Years	Guerbet

Spots Global Cancer Trial Database for gadodiamide

Every month we try and update this database with for gadodiamide cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for gadodiamide

Every month we try and update this database with for gadodiamide cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for gadodiamide cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.