# At home monitoring for 177Lu DOTATATE treatment personalization

> **NIH NIH R21** · UNIVERSITY OF WASHINGTON · 2020 · $181,741

## Abstract

For patients with metastatic, somatostatin-receptor-2 (SSTR2) positive neuroendocrine tumors (NETs),
targeted therapy using 177Lu-DOTATATE greatly increases progression-free survival (PFS), as shown in the
NETTER-1 trial. PFS at month 20 was 65.2% (95% CI, 50.0 - 76.8) for midgut NETs treated with 177Lu-
DOTATATE plus octreotide compared to 10.8% (95% CI, 3.5 - 23.0) in a control group receiving 60 mg
octreotide long-acting release every 4 weeks. Now that 177Lu-DOTATATE has FDA approval it will likely
become the standard of care for symptomatic NET patients and those with metastatic spread. However, FDA
package instructions call for patients to receive four 7.4 GBq treatments, regardless of size, weight, gender or
patient health status. Traditionally, targeted radionuclide therapies are personalized based upon dose to the
main organs at risk. Standardized therapy is counter to the ideals of personalized medicine and will lead to
non-optimum therapeutic dosing for many patients. The scientific premise of this proposal is that practical tools
to accurately assess dose to organs at risk will enable treatment personalization and improve outcomes
beyond the proposed standard of care (i.e., 4×7.4 GBq 177Lu-DOTATATE) protocol.
In Aim 1 methods to measure individual organ dose information from a wearable, low cost, multi-detector
personalized home dosimetry (MDPHD) vest will be developed using Monte Carlo simulation tools. In Aim 2, a
prototype MDPHD vest for organ specific dose estimation will be fabricated. The vest will consist of 6-15 small,
spectrographic counting detectors and weigh between 480-750 grams depending upon the number of
detectors incorporated into the vest. It will be designed to be light weight, form fitting and will have alignment
features to enable consistent day to day wearing/positioning of the vest with respect to the patient's internal
organs. Time to put on, align and collect data will be less than 8 minutes each day. The vest will further be
equipped with electronics that can acquire, store and send the data via Wi-Fi to a secure web-site for near real
time data monitoring. In Aim 3, a small pilot study to compare individual organ dosimetry estimates using a
streamlined protocol (i.e., one SPECT/CT combined with an in-clinic MDPHD vest measurement at 24-hr post-
therapy and daily at-home MDPHD vest measurements for 7-21 days) versus 3-time point (i.e., 1, 4 and 7 day)
in-clinic SPECT/CT imaging (i.e., standard protocol followed in many non-US countries) will be conducted. At
the end of this project, methods to create and utilize a MDPHD vest will have been tested and validated and
the MDPHD vests will be ready for evaluation on a larger patient cohort.

## Key facts

- **NIH application ID:** 9877278
- **Project number:** 1R21CA237788-01A1
- **Recipient organization:** UNIVERSITY OF WASHINGTON
- **Principal Investigator:** Robert S Miyaoka
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $181,741
- **Award type:** 1
- **Project period:** 2019-12-06 → 2021-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9877278

## Citation

> US National Institutes of Health, RePORTER application 9877278, At home monitoring for 177Lu DOTATATE treatment personalization (1R21CA237788-01A1). Retrieved via AI Analytics 2026-06-11 from https://api.ai-analytics.org/grant/nih/9877278. Licensed CC0.

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