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Innovation

The landscape of oncology imaging continues to evolve with the introduction and validation of novel molecular endpoints and modifications to existing response criteria. Bioclinica's oncology team have the expertise to adopt and implement the newest endpoints from the scientific literature and apply study specific modifications to existing endpoints based upon the tumor type, response criteria, drug effect, or sponsor request.

All of our oncology reviewers have experience with the latest advancements in molecular imaging and oncology biomarkers allowing for an innovative solution for your trial endpoint requirements. Our network of Key Opinion Leaders (KOLs) works together with industry and regulatory agencies to assist with the development and validation of novel molecular oncology biomarkers.

Oncology Imaging Endpoint Analysis
Imaging endpoints play a central role in oncology trials, determining patient enrollment, prognosis, diagnosis, surveillance, safety, and clinical outcome. Depending on the modality and cancer type, there are many imaging endpoints involving the assessment of tumor responses. These include disease-free survival, objective response rate, time to progression, progression-free survival, and time to treatment failure.

Correct lesion identification and tracking is vital to ensure accurate and precise interpretation during oncology clinical trials. The analysis of oncology imaging endpoints may utilize a number of response criteria, including:

  • Cheson
  • Choi
  • EBMT
  • EORTC
  • Hallek
  • IHP
  • Lugano (Cheson et al., 2014)
  • Macdonald
  • PCWG2
  • PERCIST
  • RANO
  • RECIST 1.0/1.1
  • Volumetric Assessment
  • WHO Methodology
  • Wolchock Immune Related Response Criteria

 

Bioclinica's oncology team has experience with all of these criteria and routinely supports studies using multiple modalities and endpoint analyses.

Molecular Imaging Endpoints
Molecular imaging technologies applied to oncology trials enables sophisticated measurements of molecular targets and biochemical changes in tumors. Bioclinica supports a full range of molecular imaging methodologies routinely performed to locate, stage, and monitor various cancers including:

 

 

  • 64Cu diacetyl-bis (N4-methylthiosemicarbazone) (ATSM)
  • 18F-fluorodeoxyglucose (FDG)
  • 18F-Fluoride
  • 3'-deoxy-3'-18F-fluorothymidine (FLT)
  • 18F-fluoromisonidazole (FMISO)
  • Gallium
  • 111In-octreotide
  • 123I-metaiodobenzylguanidine (mIBG)
  • Technetium-99m
  • Thallium
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Successful clinical trials require the ability to see key details and uncover hidden insights. Bioclinica utilizes science and technology to bring clarity to clinical trials, helping companies to develop new life-improving therapies more efficiently and safely.

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