NIH/NCI 459 – Automated Software for Point-of-Care Testing to Identify Cancer-Associated Malnutrition

Fast-Track proposals will be accepted.

Direct-to-Phase II proposals will NOT be accepted.

Number of anticipated awards: 2-3

Budget (total costs, per award):

Phase I: up to $400,000 for up to 12 months

Phase II: up to $2,000,000 for up to 2 years

PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED.

Summary

The NIH Office of Disease Prevention recently held a Pathways to Prevention workshop, which explored the evidence for nutritional interventions and cancer health outcomes. A report of the workshop by an independent panel recommended baseline screening for nutrition risk following cancer diagnosis and repeated through treatment. This recommendation is supported by evidence linking cancer-associated malnutrition to poorer outcomes, including decreased treatment completion, greater healthcare utilization, and overall worse survival. The poor outcomes are driven substantially by the depletion of skeletal muscle, such as in sarcopenia, and by the emerging abnormal body composition phenotype of low muscle mass and high adipose tissue or sarcopenic obesity. Nutritional screening is the first step in the identification and treatment of patients with or at risk for malnutrition, especially those patients with cancer types that have the highest prevalence of malnutrition including upper gastrointestinal, head and neck, hematological, gynecological, colorectal, and lung cancers. Several quick and simple-to-administer questionnaire-based screening tools validated in the oncology setting capture changes in appetite and unintentional weight loss; they are often short, easy to administer, and can be incorporated into the electronic health record (EHR). However, they fail to capture abnormal body composition, which is fundamental for the identification of hidden abnormalities, such as sarcopenia and myosteatosis. State-of-the-art approaches based on diagnostic imaging are available to quantify the depletion of skeletal muscle and abnormal body composition changes that occur in patients with cancer. For example, CT scans, which are accessible in most cancer populations for routine diagnosis and follow-up of treatment response, can be ‘re-purposed’ for assessing muscle and adipose tissue and is considered gold standard methodology. Biomedical image segmentation and automated segmentation of skeletal muscle and adipose tissue from CT scans provides a time-efficient, clinic-friendly, and accurate assessment of muscle and adipose tissues.

Developing an automated nutrition screener that combines the questionnaire-based tools with diagnostic imaging would greatly improve the identification of cancer patients with or at risk for malnutrition and will aid in the optimal timing for nutritional intervention.

Project Goals

The overall goal of the contract solicitation is to facilitate the commercial development of novel automated point-of-care nutrition screeners that combine first-line questionnaires with automated segmentation from diagnostic imaging, such as from repurposed CT images, to detect malnutrition risk early and repeatedly during cancer care and in cancer populations with higher prevalence of malnutrition. In the short term, patients who might be overlooked as malnourished may be able to receive nutrition therapy and avoid the physiological and metabolic alterations that contribute to worse outcomes, including patients in the early stages of cachexia or pre-cachexia, who may be responsive to treatment. In the long-term, nutritional treatment will be an integral component of cancer care and the poor outcomes associated with malnutrition will be less burdensome to those suffering from cancer.

The technical scope of this initiative encompasses the design and manufacturing of an automated screening tool for clinical use. The novel screening tool may utilize new or existing nutrition screeners, such as the Malnutrition Screening Tool, NUTRISCORE, or others, combined with existing or newly developed automated segmentation from diagnostic imaging, such as CT, DXA, MRI, ultrasound, or other body composition methodology. The tool should be quick, easy to use, and be incorporated into the EHR. Any member of the healthcare team, such as a medical technician should be able to incorporate the screener into their patient check-in.

Activities not responsive to announcement:

Tools that are lengthy, time consuming, or cumbersome to the patient or caregiver; tools that involve the use of non-standard-of-care blood sampling or other invasive examinations.

Phase I Activities and Deliverables:

Establish a project team, including proven expertise in nutrition and body composition, screening tool development, radiology, user centered design, software and hardware expertise, including in EHR, and other areas of expertise as appropriate for the project.
Applying user-centric design principles, develop a cost-effective, non-invasive, and accessible device prototype capable of nutritional screening.
Provide the design of the pilot technology.
Characterize the tool, measure the functionality, and test the quality control parameters.
Test the feasibility and acceptability of the technology within an EHR testing environment and with at least 25 patients and oncology practitioners.
Develop plans for transitioning the tool for clinical application; identify at least two clinical settings where the technology may be used and integrated for pilot user testing.
Engage stakeholders and determine clinical consensus if differing recommendations or insufficient data occur.
Include the ability to continuously incorporate new information on nutrition and body composition as it is released by the appropriate organizations.
Propose a validation plan consistent with the combined imagining device and questionnaire-based tool; imaging technology may require validation against whole body CT skeletal muscle volume; newly developed questionnaire-based screeners may require validation against tools already validated in their respective setting, such as the Subjective Global Assessment or the Patient Generated Subjective Global Assessment.
Provide the technical specifications, including privacy and security protections, as well as an operations/user guide.
Outline the metrics that can be used to assess the successful application of the technology.

Phase II Activities and Deliverables:

Develop metrics and provide a report demonstrating successful use of the technology, including comprehension of the information by oncology providers.
Conduct a validation study, as appropriate, and provide a report of the feasibility/acceptability and successful use of the integrated screening technology in a well justified sample of oncology patients.
Demonstrate reliability, robustness, and usability in clinical delivery settings.
Describe the challenges encountered during the technology development and measures taken to mitigate the challenges.
Develop a plan to implement the technology in EHR systems.
Develop a dissemination plan for the technology and a training course on the intended use of the technology.
Develop a plan for commercialization of the integrated screening technology.
Provide letter(s) of commercial interest and commitment to the project and contract officers in the first year of the Phase II contract.
Provide a report with a finalized user guide and operations manual for use of technology within a range of oncology providers; these documents will include technical specifications, process guides/flow charts for how and by who the technology will be used, and privacy and security protections.

Receipt date: November 14, 2023, 5:00 p.m. Eastern Standard Time

Apply for this topic on the Contract Proposal Submission (eCPS) website.

View the full PHS2024-1 Contract Solicitation.