NIH/NCI 448 – Wearable Devices for Dosimetry of Radiopharmaceutical Therapy

Fast-Track proposals will be accepted.

Direct-to-Phase II proposals will be accepted.

Number of anticipated awards: 3-5

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

Dosimetry for radiopharmaceutical therapy (RPT) has the potential to increase tumor control and/or decrease side effects as it is the standard of care in external beam and brachytherapy forms of radiation therapy (RT). Radiation dosimetry is a crucial tool to guide and optimize tumor control and minimize adverse toxicity to normal tissues.

The goal of this contract topic is to accelerate the development of devices that are wearable detectors of radiation emitted from therapeutic radiopharmaceuticals to perform 4D radiation dosimetry for RPT using a single or no SPECT/CT and/or PET/CT scans. A wearable (e.g., clothing-based) integrated dosimetry-sensor also opens the opportunity for out-of-clinic collection of dynamic, continuous data monitoring, which is not possible with current in-hospital SPECT/CT or PET/CT scans. These data have the potential to optimize treatment by delivery of maximum tolerated dose to the organs at risk. They will also enable assessing the efficacy of the dose delivered to the tumors, informing the treatment of individual patients. If some of the tumors receive a suboptimal dose, they might get a boost of external RT. If the dose delivered to all of the tumors is too low to be effective, then the RPT will be discontinued, and other treatment modalities will be used.

Currently, dosimetry procedures involve multiple PET/CT or SPECT/CT whole-body scans that present a challenge for hospital systems and patients. Multiple scans require extra days in the hospital, additional travel, time away from home, and/or anesthesia use as needed for young children. This problem might be solved by wearable dosimeters to be used at home. For example, a procedure could include long underwear-like clothing or Lycra with built-in sensors that collect data on dose and its distribution to be remotely transferred (synchronously or asynchronously) to a treatment planning system.

Project Goals

The goal of this concept is to develop wearable technologies (e.g., dosimetry sensor-incorporated clothing) to allow RPT dose to be measured as patients go about their activities of daily living – providing dynamic, rich, time-based dose data for RPT agents that can be correlated with the patient’s anatomy. Products that are compatible for use in the pediatric population are strongly encouraged. It is encouraged that products be able to be used across all ages of patients. The scope of proposed activities includes the engineering of new devices and/or integration of existing technology to achieve the goal. Specific supported activities would include device development and production, development of organ dosimetry data over time that is DICOM compatible, development of Q/A methods for the proposed device(s), and optimization of the interface. Proposals must include the clinical indications for the device(s).

The goals of this topic are to design and validate a wearable dosimetry clothing/device array for remote monitoring in a welldefined RPT cancer treatment scenario. Examples of possible devices include clothing that collects dose, development of different dosimeter arrangements that are tailored to specific radiopharmaceuticals, organ at risk, tumor locations, and cancers.

Phase I deliverables will include proof of concept such as a mockup of a proposed sensor array/clothing/wearable with collection of data being performed on a phantom (ideally anthropomorphic). The device can be independent of other methods or work in conjunction with existing treatment planning systems to improve dosimetry. Dose collected must be able to be stored in an electronic file format and demonstrated to the program and contract officers to move to Phase II.

Phase II deliverables will include holding at least one pre-submission meeting with the FDA, developing Q/A and related standard operating procedures, developing the means to scale up production to a clinically and commercially viable solution, being able to perform dosimetry at multiple time points, demonstrating in the first year of Phase II to program and contract officers a letter(s) of commercial interest and in the second year of Phase II providing program and contract officers with a letter(s) of commercial commitment. Capacity for DICOM export of dosimetric RPT data from the device(s) is required.

Phase I Activities and Deliverables:

Generate proof-of-concept data that demonstrate feasibility of the proposed solutions to improve quantitative accuracy and precision in RPT dose measurement.
In the first year of the contract, provide the program and contract officers with a letter(s) of commercial interest from potential end users, which might include those interested in using the solution as a research tool or in collaborating in a business venture.
Offerors should specify quantitative technical and commercially relevant milestones, that can be used to evaluate the success of the tool or technology being developed.
Offerors should develop specifications for robustness and durability of the wearable unit overall, and provide appropriate justification relevant to both the development and commercialization of these technologies.
- Additional relevant details might include context of use for the device(s); design specifications on the type(s) of radiation activity being detected; anticipated spatial configuration of detectors; methodological basis of detectors; indication of and rationale for time-integrated acquisition; indication of how the unit is powered, the basis for communication between detector elements and means for information output or export; methodology for calculating absorbed dose.
Quantitative milestones may be relative metrics (e.g. compared to currently used technologies and benchmarks or algorithms and methods) indicating clear advantages of the proposed technologies.
Build a prototype that demonstrates operability, data transferability, and strong translational potential for use and that demonstrates rigor and reproducibility in benchmark experiments using relevant RPT agents/modalities in appropriate phantoms.
In the first year of the contract, provide the program and contract officers with a letter(s) of commercial interest.

Phase II Activities and Deliverables:

Demonstrate reliability, robustness, and usability in clinical and/or preclinical RPT delivery measurement.
Propose a validation plan. Demonstrate system performance and functionality against commercially relevant quantitative milestones.
- Offerors should specify quantitative technical and commercially-relevant milestones, that can be used to evaluate the commercialization of the tool or technology being developed.
- Offerors should also provide appropriate justification relevant to both the development and scalable commercialization of these technologies.
- Quantitative assessment milestones may be relative metrics (e.g. compared to currently used systems), and/or metrics (e.g. accuracy at various dose and radiation types relative to SPECT-CT and/or PET controls; the capacity to record and report dose delivery fine structure; or a method to provide a safety analysis rapidly in an RPT context).
Show feasibility to be scaled up at a price point that is compatible with market success and widespread adoption by the cancer research and treatment communities.
In the second year of the contract, provide the program and contract officers with a letter(s) of commercial commitment.
Documentation of at least one pre-submission meeting with the FDA.

Receipt date: November 4, 2022, 5:00 p.m. Eastern Daylight Time

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

For full PHS2023-1 Contract Solicitation, c lick here.