body scan servicesUnder stated agreements, the BCAC acts as the central reading site for scans performed for clinical research, conducted by the acting sponsor. The BCAC provides all necessary services, qualified personnel, equipment, supplies and facilities for the purposes of performing DXA and/or CT scan readings and transmitting data results.

Each business agreement includes a proposed number of subjects and an amount of DXA or CT scans required for each during a determined period of time at a decided number of study locations. Options to extend the follow-up period or expand the number of subjects are determined separately as needed.

Included under each contract for Tufts services are:

  1. Performance of DXA and/or CT scan reading;
  2. Site set up:
    • Training session(s) with technicians/coordinators via webinar or conference call with Tufts personnel to review study protocol and Tufts requirements, and to establish files and communications;
    • Provision of tailored study scan manual/protocols, radiation information, and tracking and data forms;
    • Tracking of all site locations, personnel and scanning machine make/model/software to ensure consistency across sites;
    • Evaluation of quality scan performance at each site throughout study;
  3. Distribution of Whole Body Variable Composition Phantom (VCP) and/or QRM European Spine Phantom (ESP) to ensure standardization of data:
    • Shipment circulation of VCP and/or ESP and monitoring of shipments to/from sites;
    • Provision of with Phantom DXA scanning protocol and data form;
    • Reading of phantom DXA scans from each site;
    • Submission of VCP and/or ESP Phantom Analysis Report(s) to study investigator/coordinator/sponsor for study findings/manuscript;
  4. Procedure quality control and assistance during study;
  5. Regular (frequency to be determined by study preference- monthly, weekly) secure electronic transmission of data to study investigators/sponsors;
  6. Manual data quality control and double entry at study completion;
  7. Return of optical discs and other media as needed;
  8. Availability of Tufts investigators and staff for consultation throughout the study and assistance in the interpretation of findings for data analysis and manuscript preparation as needed.

Please note that DXA scans are conducted exclusively on applicable research participants. For a list of current studies, please visit the HNRCA volunteer website or contact volunteer services at 1-800-738-7555

The Body Composition Analysis Center is an unparalleled resource for:

  • Analysis of CT scans of visceral fat & subcutaneous fat for multi-center trials; analysis of CT scans for muscle & fat regional cross-sectional areas.
  • Analysis of DXA scans for soft tissue as well as bone components.

Summary of Tufts Services:

Prior to study:
Webinar and/or conference call with site study coordinators, nurse coordinators, technicians, and investigators to familiarize all parties with Tufts and study-specific protocols – proper method of scanning, proper method of transmitting scan files and data forms, study-specific timelines, troubleshooting. Site support provided for any problems throughout course of study.

Sites submit scan files, data and tracking forms (CRFs), and image report of scans. Scan files and CRFs are immediately checked for errors and discrepancies. Printouts are checked for correct and consistent scanning performance and scan date accuracy. Tufts recommends that sites email or fax all paper files and electronically upload scan files via our secure FTP server.

DXA scans are analyzed by our certified scan technician, per our standardized protocol. Hologic and Lunar scans will be analyzed using the most current software versions available. Patient scans from follow-up visits are analyzed using the baseline analysis as a guide for placing cut points and defining regions of interest. Software version will remain consistent from baseline to follow-up.

Patient scans from follow-up visits are analyzed using the baseline analysis as a guide for placing cut points and defining regions of interest.

Data provision:

Target results are manually entered into Excel spreadsheets, and uploaded to study personnel once per month (or more frequently as requested). Data is checked by internal range checks within the Excel spreadsheets and by manual double-entry.

Data backup:

Target results are manually entered into Excel spreadsheets, and uploaded to study personnel once per month (or more frequently as requested). Data is checked by internal range checks within the Excel spreadsheets and by manual double-entry.

Quality Control:
The Body Composition Analysis Center prides itself on accuracy and consistency. During the duration of each study, a phantom instrument is circulated across all sites for the calibration of DXA scanning machines. The calibration process evaluates scanner performance and validates an acceptable degree of data variation between sites.

Our spine phantom, the European Spine Phantom, is considered the standard for quality control in spinal BMD quantification. Its design is closely anthropomorphic by its outer measures and internal lumbar vertebrae inserts such that standard patient protocols can be utilized. The phantom’s main body consists of waterequivalent resin, the three inserts contain varying amounts of calcium hydroxyapatite (CaHA) to cover the full physiological range of cancellous and cortical bone densities for all age groups.

Our whole body phantom, the Bio-Imaging Variable Composition Phantom (VCP), is a body composition standard for DXA instruments. The innovative design provides soft tissue data at multiple %fat values. This phantom is ideal for comparison and standardization of several machines in a clinical body comp study. The phantom is scanned as a total body, in three different configurations to simulate a clinically appropriate range of percent fat values for instrument assessment.

Procedure for DXA Analysis

Whole body DXA scans are performed on each patient for assessment of regional body composition. Scans must be performed on study-approved GE Lunar or Hologic scanners and sent to the Tufts University Body Composition Analysis Center for analysis within the study-specific time window. Participants must be analyzed according to the Tufts University standardized analysis procedure and/or study-specific protocol.

Scans will be analyzed per manufacturer protocol unless otherwise specified by study team members. The analysis of each whole body scan will generate values for total body lean, total BMC, total body fat, total body mass, trunk fat, trunk lean, total BMD, lumbar BMD, upper extremity fat, upper extremity lean, lower extremity fat and lower extremity lean. The analysis of each whole body DXA will be performed using each patient’s baseline scan as a reference for ROI placement. To minimize error, each patient will be scanned on the same machine from baseline to termination.

In the event of a software upgrade, Tufts will re-analyze all affected baseline scans to ensure that readings are consistent and accurate. In the event of an inter-study machine chance, Tufts will work with the site to ensure smooth transition with minimal effect on study data. During the study, a single variable composition (% fat) phantom (VCP) will be sent to each site and used to account for any inter-scanner differences in body composition measurements. If bone mineral density is more of a concern than soft tissue composition, the study may opt to circulate a European Spine Phantom instead of, or in addition to, the VCP phantom.

Procedure for Abdominal CT Analysis

CT scans are sent to Tufts University as Dicom Image files. These files are analyzed using Tomovision SliceOMatic 4.3. The display field of view (DFOV) recorded on the tracking form (CRF) is used to scale the pixels for analysis. The technician uses the brush and eraser tool to remove the table and any part of medical attire recorded in the scan image. The software’s built-in macros for CT analysis are then used to analyze each scan. Results are generated for total abdominal area, total subcutaneous adipose tissue (SAT), and total visceral adipose tissue (VAT). Results are recorded on an “Abdominal Analysis” form and kept in Tufts University’s records. All values are uploaded to the Tufts database and backed up on a daily basis.”