Neoplasms

All Conditions

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

A group of up to 8 subjects to receive a single dose of BR55 at 0.03mL/kg.

A group of up to 8 subjects to receive a single dose of BR55 at 0.05mL/kg.

A group of 8 subjects to receive a single dose of BR55 at 0.08mL/kg.

A novel targeted ultrasound contrast agent

BR55

Maria Luigia Storto, MD

This is an exploratory, single center, open label, parallel-dose, and prospective study of BR55 CEUS for characterization of solid pancreatic lesions in subjects with suspected PDAC using transabdominal US.

Approximately twenty-four (24) subjects with suspected PDAC and scheduled to undergo surgical resection within 30 days (but not before 24 hours) after the transabdominal BR55 CEUS examination will be enrolled into 3 dose groups, 0.03, 0.05, and 0.08 mL/kg, with a maximum of 8 patients in each dose group.

Up to 24 subjects will be enrolled into 3 dose groups starting with the lowest dose group as follows: Dose group 0.03mL/kg, dose group 0.05mL/kg and dose group 0.08mL/kg/, with a maximum of 8 patients in each dose group.

Transabdominal Ultrasound With BR55 for Characterization of Pancreatic Lesions

BR55-enhanced images will be visually assessed using a 3-point scale (no enhancement, weak enhancement, strong enhancement).

Number of participants who received the contrast agent and experienced an adverse event.

National Institutes of Health (NIH)

Bracco Diagnostics, Inc

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Ovarian Cancer

Ovarian Epithelial Cancer

Menopause

BR55 will be performed in the early follicular phase first and in the late follicular phase thereafter.

BR55 will be performed in the late follicular phase first and in the early follicular phase thereafter.

BR55 will be administered at doses of 0.03 mL/kg or 0.05 mL/kg

Luigia Storto, MD

This is an exploratory, single center, open label, prospective study of BR55 to determine the optimal phase of the menstrual cycle for performing BR55 CEUS of the target ovary in premenopausal women scheduled to undergo preventative surgery because of high familial/hereditary or genetic risk for ovarian cancer.

Group A: BR55 CEUS will be performed in the early follicular phase first and in the late follicular phase thereafter; Group B: BR55 CEUS will be performed in the late follicular phase first and in the early phase thereafter.

Female subject of at least 18 years of age

Optimal Timing of BR55 CEUS of the Ovaries

An Exploratory Study to Determine the Optimal Timing of BR55 Contrast Enhanced Ultrasound (CEUS) of the Ovaries in Pre-menopausal Women

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

One to two bolus (2nd bolus optional) of BR55 per patient

Hessel Wijkstra, Dr.

The purpose of this study is to determine whether BR55 is able to identify areas of VEGFR2 expression in human prostate by ultrasound molecular imaging.

This will be compared with histopathology analysis (location based on expression of VEGFR2 in tissue specimens determined by immuno-histochemistry, IHC).

BR55 in Prostate Cancer: an Exploratory Clinical Trial

Exploratory Clinical Trial Using BR55 Targeted Ultrasound Contrast Agent in the Detection of Prostate Cancer by Molecular Imaging of VEGFR2

Assess the ability of BR55 to identify area(s) of VEGFR2 expression in human prostate by ultrasound molecular imaging on the basis of a visual score in comparison with histopathology analysis (location based on expression of VEGFR2 in tissue specimens determined by immuno-histochemistry, IHC).

Evaluate the specificity of BR55 targeting for prostate cancer relative to normal prostate gland on the basis of a visual score in comparison with routine histopathology analysis and IHC assessment of VEGFR2 expression in tissue specimens.

Bracco Imaging S.p.A.

All patients received BR55 as a single intravenous injection at the dose of 0.03 mL/kg...

Maria Luigia Storto, M.D.

Pilot study to evaluate the ability of BR55 to identify prostate cancer lesions with Gleason Score ≥7 by ultrasound molecular imaging on the basis of a visual score in comparison with histopathology results

This multi-centre, open label, prospective, pilot study was designed to assess the ability of BR55 to detect VEGFR2 in human prostate cancer by Ultrasound Molecular Imaging (USMI). The binding of BR55 to VEGFR2 (focal enhancement still visible after significant decrease in signal from circulating microbubbles seen) was assessed at USMI and VEGFR2 expression was to be confirmed by immunohistochemistry (IHC) analysis including VEGFR2 and CD31 staining.

A Pilot Trial Using BR55 Ultrasound Contrast Agent in the Assessment of Prostate Cancer

A Pilot Clinical Trial Using BR55 Ultrasound Contrast Agent in the Assessment of Prostate Cancer by Molecular Imaging of VEGFR2

To assess the ability of BR55 to identify prostate cancer lesions with a Gleason score ≥ 7 using histopathology as truth standard

To obtain safety data in subjects administered BR55

All patients received BR55 as a single intravenous injection at the dose of 0.03 mL/kg

Age, Continuous

18-64 years

>= 65 years

Age, Customized

Sex: Female, Male

American Indian or Alaska Native

Asian

Black

Native Hawaiian or Other Pacific Islander

White

Other

Race/Ethnicity, Customized

Weight

Height

Maria Luigia Storto, MD, Executive Director X-Ray and Ultrasound

Gleason score ≥7

With binding

BR55 binding level versus Gleason score in malignant lesions from off-site histopathology

Spots Global Cancer Trial Database for br55

Every month we try and update this database with for br55 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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Transabdominal Ultrasound With BR55 for Characterization of Pancreatic Lesions	NCT03486327	Pancreatic Duct...	BR55	18 Years -	Bracco Diagnostics, Inc
Optimal Timing of BR55 CEUS of the Ovaries	NCT04248153	Ovarian Cancer	BR55	18 Years -	Bracco Diagnostics, Inc
BR55 in Prostate Cancer: an Exploratory Clinical Trial	NCT01253213	Prostate Cancer	BR55	40 Years -	Bracco Diagnostics, Inc
BR55 in Prostate Cancer: an Exploratory Clinical Trial	NCT01253213	Prostate Cancer	BR55	40 Years -	Bracco Diagnostics, Inc
A Pilot Trial Using BR55 Ultrasound Contrast Agent in the Assessment of Prostate Cancer	NCT02142608	Prostate Cancer	BR55	50 Years - 70 Years	Bracco Diagnostics, Inc

Spots Global Cancer Trial Database for br55

Every month we try and update this database with for br55 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 br55 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.