Neoplasms

All Conditions

Symptoms and General Pathology

Musculoskeletal Diseases

Infections

Skin and Connective Tissue Diseases

Rare Diseases

Sarcoma

Necrosis

Osteonecrosis

Osteomyelitis

Osteosarcoma

Sarcoma, Ewing

Chondrosarcoma

Bone Neoplasms

Rhabdomyosarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Myosarcoma

Communicable Diseases

Bone Diseases

Bone Diseases, Infectious

Soft Tissue Sarcoma

Ewing Sarcoma

Hematinics

Pharmaceutical Solutions

All Drugs and Chemicals

Ferrosoferric Oxide

Parenteral Nutrition Solutions

Intravenous injection of Feraheme, 5 mg Fe/kg

5 mg/kg by intravenous (IV) administration

Feraheme

Standard of Care magnetic resonance imaging (MRI) scans using GE 1.5T and 3T MRI scanners/

Magnetic Resonance Imaging (MRI) scan

Heike E Daldrup-Link, MD

Neyssa Marina, MD

This pilot trial studies the differentiation of bone sarcomas and osteomyelitis with ferumoxytol-enhanced magnetic resonance imaging (MRI). Imaging procedures that allow doctors to more accurately differentiate between malignant bone sarcomas and osteomyelitis may help in diagnosing patients correctly and may result in more timely treatment.

BACKGROUND; In this study, T1, T2, and T2\* represent parameters of magnetic resonance imaging (MRI).

The T1 relaxation time, also known as the spin-lattice relaxation time, is a measure of how quickly the net magnetization vector (NMV) recovers to its ground state in the direction of B0. T1 is assessed immediately post-contrast. A T1-weighted image (T1WI ) is one of the basic pulse sequences in MRI and demonstrates differences in the T1 relaxation times of tissues. A T1WI relies upon the longitudinal relaxation of a tissue's net magnetization vector (NMV).

T2 is a time constant for the decay of transverse magnetization arising from natural interactions at the atomic or molecular levels, and be considered the "natural" or "true" T2 of the tissue. However, in any nuclear magnetic resonance (NMR) experiment, transverse magnetization decays much faster than would be predicted by natural atomic and molecular mechanisms. Accordingly, T2 \* is the time constant for the decay of transverse magnetization as observed in a tissue during a MRI scan, and be considered the"effective T2" (represented as T2\*). T2\* is always ≤ T2. In this study, T2 \* is assessed after 24 hours.

OUTLINE:

Patients receive ferumoxytol intravenously (IV) and then undergo ferumoxytol-enhanced MRI up to 1 hour after infusion and up to 24 hours post-infusion.

PRIMARY OBJECTIVES:

* Establish magnetic resonance (MR) imaging characteristics of bone sarcomas and osteomyelitis based on their ferumoxytol-enhancement on relatively early post-contrast T1-weighted images.
* Establish MR imaging characteristics of bone sarcomas and osteomyelitis based on their ferumoxytol-enhancement on delayed postcontrast T2-weighted images.
* Establish T2-weighted MR imaging characteristics of iron-labeled mesenchymal stem cell (MSC) in osteonecrotic bone over time, before and after surgical core decompression and bone marrow implantation.
* Adding a second branch for patients who can not receive ferumoxytol but still getting the MRI exam. These patients will server as controls.

Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI

Pilot Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI

Differentiation of bone sarcomas and osteomyelitis with ferumoxytol-enhanced magnetic resonance imaging (MRI) was assessed as the difference of mean T2 \* relaxation time of bone sarcoma and osteomyelitis subjects. The outcome is reported as the difference of the mean T2 \* values, with standard deviation.

Differentiation of bone sarcomas pre-ferumoxytol and post-ferumoxytol contrast was assessed by difference of mean T2 \* relaxation time pre-ferumoxytol and post-ferumoxytol contrast, in bone sarcoma subjects only.

Differentiation of lymphoma from bone sarcoma was assessed as the difference of mean T2 \* relaxation time determined by ferumoxytol-enhanced MRI.

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Differentiation of CD68-positive tumor-associated macrophages (TAM) between lymphoma and bone sarcoma was assessed as the difference of mean area density of CD68-positive TAM in those populations.

Differentiation of CD163-positive tumor-associated macrophages (TAM) between lymphoma and bone sarcoma was assessed as the difference of mean area density of CD163-positive TAM in those populations.

Heike E Daldrup-Link

Professor of Radiology (General Radiology)

Intravenous injection of Feraheme, 5 mg Fe/kg

Feraheme: 5 mg Fe/kg iv

MR Scan: Standard of Care

Intravenous injection of Feraheme, 5 mg Fe/kg

Feraheme: 5 mg Fe/kg by intravenous adminstration

MR Scan: Standard of Care

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Heike Daldrup-Link

Participants with bone sarcomas (osteosarcomas and Ewing sarcomas) evaluated with ferumoxytol-enhanced MRI.

Bone Sarcomas

Participants with osteomyelitis evaluated with MRI with ferumoxytol enhancement.

This initial phase of the study was a pilot assessment of participants with bone sarcomas compared to participants with osteomyelitis.

T2* Relaxation Time of Bone Sarcomas and Osteomyelitis Subjects

Pre-treatment

Post-treatment

Participants with bone sarcomas (osteosarcomas and Ewing sarcomas) only.

Bone Sarcomas Pre-ferumoxytol & Post-ferumoxytol Contrast

Only the participants with bone sarcomas were evaluated for this outcome.

Differentiation of Bone Sarcomas Pre-ferumoxytol and Post-ferumoxytol Contrast

Participants with lymphoma evaluated with ferumoxytol-enhanced MRI

Mean T2 * Relaxation Time for Lymphoma Participants

Participants with bone sarcoma, evaluated with ferumoxytol-enhanced MRI

Mean T2 * Relaxation Time for Bone Sarcoma Participants

The analysis population for this outcome includes the participants with bone sarcoma who participated in the pilot study.

Differentiation of Lymphoma and Bone Sarcomas With Ferumoxytol-enhanced MRI

CD-68-positive tumor-associated macrophages (TAM) assessed in Lymphoma participants

Mean Area Density of CD-68-positive TAM in Lymphoma

CD-68-positive Tumor associated macrophages(TAMs)in Bone Sarcomas participants

Mean Area Density of CD-68-positive TAM in Bone Sarcomas

Differentiation of CD68-positive Tumor-associated Macrophages (TAM) in Lymphomas and Bone Sarcomas

CD163-positive tumor-associated macrophages (TAM) was assessed in participants with lymphoma

Mean Area Density of CD163-positive TAM in Lymphoma

CD163-positive tumor-associated macrophages (TAM) was assessed in participants with bone sarcomas

Mean Area Density of CD163-positive TAM in Bone Sarcoma

Differentiation of CD163-positive Tumor-associated Macrophages (TAM) in Lymphomas and Bone Sarcomas

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma, Renal Cell

Kidney Neoplasms

Carcinoma

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Renal Cell Carcinoma

Anticoagulants

Micronutrients

Edetic Acid

Pentetic Acid

Antidotes

Protective Agents

Chelating Agents

Iron

Iron Chelating Agents

Patients will be enrolled for 2 MRI visits. These visits will include an approximately 1 hour research MRI scan and a total of between 3 and 5 hours Tc-99m DTPA scan.

In each MRI visit, patients will be scanned for approximately one hour including both standard-of-care clinical sequences and research-based Advanced Diffusion Imaging sequences, on a Prisma 3T MRI scanner. Following the MRI exam or on a day not more than a week after the MRI exam, patients will undergo renal function assessment via Tc-99m DTPA scan and patient's kidneys will be scanned using a gamma camera. Proteinuria will be assessed by standard of care urinalysis of specimens collected at each MRI visit for each patient. Blood test will be performed at each visit to estimate GFR (eGFR) from measurement of serum creatinine.

Participants will undergo a 1-hour research MRI scan.

Magnetic Resonance Imaging (MRI) Scan

Participants will receive radioisotope (99mTc-DTPA) injection (5 mCi) during 3-5 hour scanning session to estimate measured glomerular filtration rate (mGFR).

Tc-99m Pentetate

Malika Kumbella

Eric Sigmund, PhD

The objective of this study is to apply advanced diffusion imaging in a two-pronged assessment of renal mass patients: (1) characterization of lesion malignancy and subtype, and (2) prediction of renal function stability or decline following partial nephrectomy.

Advanced Diffusion Imaging in Renal Cancer Patients

Advanced Diffusion Imaging in Renal Cancer Patients: Oncologic Control and Renal Functional Reserve

This project does not contain provisions for generating public databases of anonymized individual data for future outside research. Consistent with the research plan of our funded study and the associated IRB protocol, the results of the study are made available at the aggregate level in the form of peer-reviewed publications.

Intravoxel incoherent imaging-MRI (IVIM-MRI) data will be used to predict lesion type.

Results from the Renal Flow and Microstructure AnisotroPy-MRI (REFMAP-MRI) pre-surgical scan will be considered as predictors for either stability in renal function or incremental decline in renal function following surgery that would lead to chronic kidney disease (CKD), as defined by mGFR values and proteinuria status at follow-up.

Post-surgical renal insult will be assessed based on either mGFR decline by over 2 ml/min/1.73 m2 per year or the appearance of proteinuria.

National Institutes of Health (NIH)

NYU Langone Health

Prostatic Neoplasms

Genital Neoplasms, Male

Genital Diseases

Genital Diseases, Male

Prostatic Diseases

Gastrointestinal Agents

Gastrins

Bombesin

Gastrin-Releasing Peptide

Neurotransmitter Agents

Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.

68Ga-DOTA-Bombesin is a gallium-68-labeled gastrin-releasing peptide receptor (GRPr) antagonist. DOTA is \[4,7,10-Tris-(carboxymethyl)-1,4,7,10-tetraazacyclododec-1-yl\]-acetyl.

68Ga-DOTA-Bombesin is administered intravenously (IV)

68Ga-DOTA-Bombesin

Positron Emission Tomography (PET) scan

Andrei Iagaru

This clinical trial studies the use of gallium-68 (68Ga)-DOTA-Bombesin as the imaging agent for positron emission tomography (PET)/magnetic resonance imaging (MRI), collectively PET-MRI, in patients with prostate cancer. PET uses a radioactive substance called 68Ga-DOTA-Bombesin, which attaches to tumor cells with specific receptors on their surfaces. The PET scanner takes pictures that capture where the radioactive drug is "lighting up" and attaching to tumor cells, which may help doctors recognize differences between tumor and healthy prostate tissue. MRI uses radio waves and a magnet to make a picture of areas inside the body. Using 68Ga-DOTA-Bombesin in diagnostic procedures, such as PET/MRI, may allow doctors to identify smaller tumors than standard imaging.

PRIMARY OBJECTIVES:

I. To evaluate the feasibility and biodistribution of 68Ga-DOTA-Bombesin (BAY 86-7548 or 68Ga-DOTA RM2).

OUTLINE:

Patients receive 68Ga-DOTA-Bombesin intravenously (IV) and then undergo PET/MRI approximately 1 hour later.

After completion of study, patients are followed up at 24 hours and 1 week.

68Ga-DOTA-Bombesin PET/MRI in Imaging Patients With Prostate Cancer

68Ga-DOTA-Bombesin PET/MRI in the Evaluation of Patients With Prostate Cancer: A Feasibility Study

Radiopharmaceutical uptake in normal organs will be evaluated visually and measured semi-quantitatively using standardized uptake values (SUV) derived from the PET/CT scan software in patients with prostate cancer. Uptake values in different tissues will be measured as SUVmean (mean value for SUV). SUVmean values reflect relative uptake of the radiolabel into the tissue.

Feasibility of 68Ga-DOTA-Bombesin as a radiopharmaceutical for PET/MRI was assessed as the percentage of enrolled subjects who complete the examination, and for which the PET/MRI data were evaluable.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Differentiation of Bone Sarcomas and Osteomyelitis With Ferumoxytol-Enhanced MRI	NCT01336803	Bone Cancer Chondrosarcoma Ewing's Sarcoma Osteosarcoma Rhabdomyosarcom... Bone Necrosis Bone Sarcoma Osteomyelitis	Feraheme Magnetic Resona...	10 Years - 21 Years	Stanford University
Advanced Diffusion Imaging in Renal Cancer Patients	NCT06116253	Renal Cancer	Magnetic Resona... Tc-99m Pentetat...	21 Years - 85 Years	NYU Langone Health
68Ga-DOTA-Bombesin PET/MRI in Imaging Patients With Prostate Cancer	NCT02440308	Prostate Carcin...	68Ga-DOTA-Bombe... Magnetic Resona... Positron Emissi...	19 Years -	Stanford University

Spots Global Cancer Trial Database for magnetic resonance imaging (mri) scan