STATEMENT-OF-WORK-R+D_imaging_tools.docx

Statement of Work Develop and Validate Navigation and Guidance tools

INTRODUCTION/OVERVIEW

The NIH Center for Interventional Oncology is an interdisciplinary effort with the primary goal of developing and better defining novel local, regional, or combination cancer therapies in patients with localized or organ-confined neoplasms. The goals are achieved via collaborations between imaging scientists, interventional radiologists, oncologists (surgical, medical, radiation, or urological), biologists, chemists, and engineers.

Medical imaging has been used to reduce invasiveness and improve precision of surgical procedures. In image-guided therapy (IGT), planning, performing, and evaluating surgery can be aided with 2D/3D medical imaging, including but not limited to magnetic resonance imaging (MRI), computed tomography (CT), ultrasound, and angiography. IGT improves surgical accuracy and outcome, so that hospital stays can be shortened and patients are less likely to need to return for further treatment. IGT can improve not only the precision of traditional surgery, but enable new surgeries in which robotic instruments access internal organs and tissues with no or minimal incision. Tracking and navigation software and hardware has been reported to integrate with IGT to further improve procedures and expand surgical abilities.

1.1 BACKGROUND

Advanced imaging methods have ushered in an era of earlier detection of cancers that are frequently localized to a single organ or region. Interventional oncology often provides cancer patients with local or regional treatment options to augment the standard systemic treatment options like: chemotherapy, surgery, and radiation. CIO investigators will leverage the interdisciplinary, translational environment at the CC to investigate and optimize how and when to combine drugs, devices, and multimodal imaging navigation.

One such example has been the use of electromagnetic tracking to diagnose and treat cancer. This led to protocol 2005-CC-0091, 16-C-0010, and 16-CC-0098 studies used to diagnose and treat prostate cancer. Continuing on this path we are hoping to increase the accuracy of imaging techniques married to noninvasive interventional procedures.

1.2 SCOPE

The goal of this contract is to improve needle placement in clinical practice. Image-guided needle insertion is a promising method for fulfilling the project goal, but the navigation and guidance tools must be cost-effective, accurate, and ergonomic to be clinically feasible. The proposed system’s hardware includes a compact guidance platform that tracks needle-based interventional instruments, and provides navigation information to the clinician during the procedure. The system will be designed to assist with cancer treatment planning and procedure execution.

The deliverables of this contract is a set of fully integrated needle-guidance prototypes that is ready for human clinical trials. The system will be prototyped and evaluated in a live animal/human study to quantify the targeting accuracy and workflow for CT, Cone Beam CT, and Ultrasound-guided procedures

· 25 X prototype CT table mounted biopsy holders

· 25 X prototype CT table mounted ablation catheter holders

· 25 X prototype CT table mounted ultrasound holders

· 25 X prototype universal long arm device holders for multiple-propose procedures

· 25 X prototype universal MEMS tracking beacons for multiple-propose tracking

· 25 X prototype MRI visible grid fiducial markers for prostate transperineal procedures

· 25 X prototype MRI visible grid fiducial markers for abdominal procedures

· 25 X prototype CT visible grid fiducial markers for prostate transperineal procedures

· 25 X prototype CT visible grid fiducial markers for abdominal procedures

· 25 X prototype ultrasound calibration kits

1.3 OBJECTIVES

1) The hardware prototype to be delivered in this contract is a compact snap-on needle clip attachable to any standard needles that provides MEMS inertial-based angular tracking. The clip design is made wireless via Bluetooth, allowing the navigation device to be easily attached to and removed from any standard needles, which minimizes its impact on the clinical workflow. The device allows for navigation during procedures by providing real-time angular tracking of needles, catheters, or interventional tools. Visual guidance will improve targeting accuracy, and leading to a reduction of procedure time and risks.

2) The software prototype to be delivered in this contract is a robust platform that (1) wirelessly connect with multiple trackers, (2) segment the tumor and facilitate path planning, and (3) provide real-time image guidance by showing the predicted needle trajectory in relation to the target. Angular navigation of the needle will be performed with the assistance of real-time multi-planar-reconstruction of CT images and auditory feedback. A lightweight version of the software will also be available on smartphones and tablets. Although the software will be optimized for tumor biopsy and treatment, the system can be adapted for use in other needle-based clinical applications.

3) Clinical validation. The software and hardware prototype will be used to segment, plan, and execute treatment. The accuracy of the system will be calculated in terms of needle placement relative to nodule locations, and evaluated for both individual needle placements and overlapping needle placements.

2.0 REQUIREMENTS

2.1 TASKS

This section defines the tasks that the contractor must complete during contract performance. The description of task requirements will depend on the approach that is selected to describe the required effort. This section should specify requirements clearly so that all readers can understand them. Reference only the absolute minimum applicable specifications and standards needed. Tailor specifications and other documents and separate general information from direction. For a Performance-Based Work Statement, this section should describe requirements in terms of results required rather than the methods for completing the work. This latitude will permit the contractor to develop new and innovative ways to complete those tasks. This section must also describe requirements in a way that permits contractor personnel to perform the service without direct Government supervision. The SOW should not include words that appear to indicate that the Government is managing day-to-day operations.

2.2 DELIVERABLES

The deliverables of this contract is a set of fully integrated needle-guidance prototypes that is ready for human clinical trials. The system will be prototyped and evaluated in a live animal/human study to quantify the targeting accuracy and workflow for CT, Cone Beam CT, and Ultrasound-guided procedures.

Hardware prototype to be delivered in this contract is a compact snap-on needle clip attachable to any standard needles that provides MEMS inertial-based angular tracking Software prototype to be delivered in this contract is a robust platform that (1) wirelessly connect with multiple trackers, (2) segment the tumor and facilitate path planning, and (3) provide real-time image guidance by showing the predicted needle trajectory in relation to the target Clinically validated prototyping of software hardware imaging navigation tools.

Specific Instrument Descriptions and Deliverables:

· 25 X prototype CT table mounted biopsy holders

· 25 X prototype CT table mounted ablation catheter holders

· 25 X prototype CT table mounted ultrasound holders

· 25 X prototype universal long arm device holders for multiple-propose procedures

· 25 X prototype universal MEMS tracking beacons for multiple-propose tracking

· 25 X prototype MRI visible grid fiducial markers for prostate transperineal procedures

· 25 X prototype MRI visible grid fiducial markers for abdominal procedures

· 25 X prototype CT visible grid fiducial markers for prostate transperineal procedures

· 25 X prototype CT visible grid fiducial markers for abdominal procedures

· 25 X prototype ultrasound calibration kits The holder and tracker devices will be fabricated using CNC, 3D printing and vacuum forming technologies and will be sterilized and made deposable. The contract deliverables include electronics, mechanical protection cases, device holders, and software source code

2.3 SCHEDULE

This project consists of 3 key milestones (see below) Milestones 1, 2 and 3 will be completed by 4 months, 8 months and 12 months after the effective date of this contract C.1. (Milestone#1) The hardware prototype to be delivered in this contract is a compact snap-on needle clip attachable to any standard needles that provides MEMS inertial-based angular tracking. The clip design is made wireless via Bluetooth, allowing the navigation device to be easily attached to and removed from any standard needles, which minimizes its impact on the clinical workflow. The device allows for navigation during procedures by providing real-time angular tracking of needles, catheters, or interventional tools. Visual guidance will improve targeting accuracy, and leading to a reduction of procedure time and risks.

C.2. (Milestone#2) The software prototype to be delivered in this contract is a robust platform that (1) wirelessly connect with multiple trackers, (2) segment the tumor and facilitate path planning, and (3) provide real-time image guidance by showing the predicted needle trajectory in relation to the target. Angular navigation of the needle will be performed with the assistance of real-time multi-planar-reconstruction of CT images and auditory feedback. A lightweight version of the software will also be available on smartphones and tablets. Although the software will be optimized for tumor biopsy and treatment, the system can be adapted for use in other needle-based clinical applications.

C.3. (Milestone#3) Clinical validation. The software and hardware prototype will be used to segment, plan, and execute treatment. The accuracy of the system will be calculated in terms of needle placement relative to nodule locations, and evaluated for both individual needle placements and overlapping needle placements.

1. 25 X prototype CT table mounted biopsy holders

2. 25 X prototype CT table mounted ablation catheter holders

3. 25 X prototype CT table mounted ultrasound holders

4. 25 X prototype universal long arm device holders for multiple-propose procedures

5. 25 X prototype universal MEMS tracking beacons for multiple-propose tracking

6. 25 X prototype MRI visible grid fiducial markers for prostate transperineal procedures

7. 25 X prototype MRI visible grid fiducial markers for abdominal procedures

8. 25 X prototype CT visible grid fiducial markers for prostate transperineal procedures

9. 25 X prototype CT visible grid fiducial markers for abdominal procedures

10. 25 X prototype ultrasound calibration kits Items 1-5 and items 6-10 in the deliverables will be delivered by 6 months and 12 months after the effective date of this contract.

2.4 ASSUMPTIONS

To complete the tasks of this contract. The chosen vendor will need to have access to 3D printer, CNC fabrication, and vacuum fabrication. Highly skilled PhD scientists to design prototypes, test and validate prototypes. A post-baccalaureate level assistant in the workshop.

3.0 GOVERNMENT FURNISHED PROPERTY

There is no government furnished property in this SOW.

4.0 SECURITY REQUIREMENTS

The contactor staff must follow all security rules and regulations to gain access to the NIH campus including but not limited to:

1) Required to show one (1) form of identification (a government-issued photo ID-driver's license, passport, green card, etc.) and to state the purpose of their visit

2) Federal law prohibits the following items on Federal property: firearms, explosives, archery equipment, dangerous weapons, knives with blades over 2½ inches, alcoholic beverages and open containers of alcohol.

3) Vendor owned or rented vehicle must go through the Gateway Vehicle Inspection Station (Building 66A), and the vendor must obtain a visitor badge

4) Vendor must contact a Wood Lab staff member for access to the IRL.

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