Expertise
Micron’s experience covers a wide variety of therapeutic areas including oncology, cardiovascular diseases, ophthalmology, orthopedics, central nervous system (CNS), dermatology, etc.
Oncology
Micron has a wide range of expertise in providing central image review services for anti-cancer drug clinical trials. Micron’s experience spans all clinical study levels including Phase I, II, III, PMS (Post Market Studies), and Investigator Initiated Trials (IIT).
Cancer Types
- Bladder
- Brain /Head and Neck
- Breast
- Cholangiocarcinoma
- Colorectal
- Esophageal
- Gallbladder
- Kidney
- Leukemia
- Liver
- Lung
- Malignant Pleural Mesothelioma
- Malignant Lymphoma
- Melanoma
- Neuroendocrine Tumors
- Ovarian
- Pheochromocytomas
- Prostate
- Stomach
Response Criteria
- RECIST (1.0, 1.1)
- mRECIST
- irRECIST
- iRECIST
- irRC
- PERCIST
- Cheson (1999, 2007)
- Lugano
- RECIL
- RANO
- WHO Criteria
- PCWG2
- PCWG3
- NCI WG Guideline
- IPCG
- IWWM Criteria
- Tsukasaki Criteria
Modalities
- CT
- MRI
- PET
- SPECT
- Gamma Camera
- Endoscope
Case Study
In addition to existing read criteria, in some studies we have included study-specific indicators to evaluate. In one such case we partnered with a sponsor and a KOL to create a new oncology assessment methodology that included tumor volumetric measurements. We often perform tumor volumetric analyses on complex tumor shapes. The existing response criteria (RECIST 1.1) is not ideal for these lesion types. Our modified response criteria, including volumetric measurements, led to more clear and successful clinical trial results. Let our team work through new read criteria ideas with your team in upcoming exploratory oncology studies.
Cardiology
Our expertise lies in providing comprehensive solutions tailored to the unique demands of cardiology. Micron understands the critical role that accurate imaging plays in assessing drug effectiveness. We offer specialized services aimed at simplifying the intricate process of image acquisition and analysis. By addressing the complexities associated with cardiology imaging, we pave the way for more precise evaluations and enhanced drug development strategies.
Modality
- SPECT/PET
- MRI
- CT
- Echo
- IV-OCT
- IVUS
- Angiography
Evaluation Items
- Myocardial Viability, Cardiac Function
- Cardiac Function, Infarct Size, Salvage Index
- Agatston Calcium Score, Pulmonary Artery Measurement
- Cardiac Function, Motion Score, Strain Analysis
- Coronary Artery Analysis (Stenosis, Stent Expansion, Plaque Characteristics, Thrombus, etc.)
- Coronary Artery Analysis (Atheroma Volume, Characteristics, etc.)
- Coronary Arterial Stenosis, BARI Score
Dermatology
The need for central reading has been increasing recent years in developments of regenerative medicine and generic drugs even for dermatology. Micron provides image analysis services for dermatology clinical trials.
Diseases
- Onychomycosis
- Wound Care
- Alopecia Areata
- Epidermolysis Bullosa
Ophthalmology
In ophthalmology, many drugs and medical devices have recently been developed in areas such as age-related macular degeneration. Micron has been supporting ophthalmology drug development studies for more than 10 years and is capable of handling Optical Coherence Tomography (OCT), fundus fluorescein angiography (FA/IA) and fundus auto fluorescence (FAF) images.
Diseases
- Age-related Macular Degeneration (AMD)
- Detached Retinas
- Diabetic Retinopathy
- Epiretinal Membrane
- Glaucoma
- Iris Pigmentation
- Macular Edema
- Macular Holes
Modalities
- OCT
- FAF
- FA/IA
- Fundus photography
Central Nervous System (CNS)
Micron has operated clinical trials in CNS imaging such as Alzheimer’s Disease (AD), and cerebral infarction (see full list below). Micron also supports phantom studies related to CNS imaging.
Diseases
- Alzheimer’s Disease (AD)
- Brain Tumors
- Cerebral Aneurysm
- Cerebral Infarction
- Depressive Disorders
- Multiple Sclerosis
Modalities
- CT
- MRI
- PET
- Brain-Angio
Scoring
- Barkhof Grand Total Scale (BGTS)
- Severity Scales of ARIA E/ARIA H
- ASPECTS-DWI
- pc-ASPECTS-DWI
Imaging Method
- DaT scan
- Amyloid PET
- FDG PET
- Tau PET
Orthopedics, Musculoskeletal
Micron is experienced in semi-quantitative (SQ) and quantitative measurement (QM) methods in various orthopedic areas (see below). For examples: DEXA bone density assessment, and quantitative assessments such as T2 mapping, in addition to other traditional orthopedic image analyses such as the Kellgren and Lawrence system and Pfirrmann grading.
Modalities
- X-Ray
- CT
- MRI
- DEXA
Diseases
- Achilles tendon
- Artificial hip joint
- Intervertebral disk displacement
- Knee osteoarthritis
- Lumbar interbody fusion
- Muscular dystrophy
- Osteoporosis
- Vertebral Body Fractures
NASH, NAFLD Imaging
Micron provides imaging analysis services for metabolic disorders such as diabetes, obesity, non-alcoholic fatty liver disease (NAFLD), and non-alcoholic steatohepatitis (NASH). Our metabolic imaging endpoint measurements include hepatic fat fraction (HFF) and hepatic fibrosis. Additionally, we can perform volumetric analysis of liver and spleen.
Modality
- X-Ray
- CT
- MRI
- MRE
Evaluation Methods
- Proton-Density Fat Fraction (PDFF)
- Liver Stiffness from MRE
- Liver and Spleen Volume (CT / MRI)
Respiratory
Modality
- X-Ray
- HRCT
- CT
Disease
- Acute Respiratory Distress Syndrome (ARDS)
- COPD
- Interstitial Lung Disease (ILD)
Gynecology
Modality
- MRI
- Laparoscopy
- Transvaginal ultrasound
Disease
- Endometriosis
- Uterine fibroid
- Adenomyosis
Criteria
- r-ASRM Score
- Enzian Classification
- EFI score
Regenerative Medicine
In this field, the study sponsor is looking for a way to see if the cells are regenerating. Micron offers suggestions based on its experience on how the degree of cellular regeneration can be assessed with images.
Diseases
- Heart disease
- Brain disease
- Respiratory
- Knee disease
- Dermatology
- Oncology
Other Advanced Analysis
Our specialized team can deliver tailor-made image data analysis services and trial support to the sponsor.
Dosimetry
Tumor Volume
Organ Volume (Liver, Spleen, Pancreas)
Brain Analysis
– Ischemic Core
– SUV (Standard Uptake Value)
– Perfusion
– Tractography
Calcification
Bone Age
Visceral Fat Volume
Achilles Tendon Thickness (Familial Hypercholesterolemia Diagnosis)
In addition, Micron have experience for supporting clinical trials in Pediatrics, Dental, and Rare disease.
Contact to learn more about our expertise
Micron is not limited by the expertise described above. We are open to listening when you are exploring new imaging related trials/studies. Our team is always open for consultations and ready to work with you on the appropriate solutions. Feel free to contact us and we’ll be in touch shortly.
