Evidence map›Paper›PMID 34242160›Full record

ArticleIEEE transactions on bio-medical engineering2022

The Translational and Regulatory Development of an Implantable Microdevice for Multiple Drug Sensitivity Measurements in Cancer Patients.

Christine Dominas, Sharath Bhagavatula, Elizabeth Stover, Kyle Deans, Cecilia Larocca, Yolanda Colson, Pierpaolo Peruzzi, Adam Kibel, Nobuhiko Hata, Lillian Tsai and 3 more

Open access · hybridAbstract read
In one paragraph

Article in IEEE transactions on bio-medical engineering, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.1field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 17 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 2 institutions in 1 country.

Christine Dominas
Sharath Bhagavatula
Elizabeth Stover
Kyle Deans
Cecilia Larocca
Yolanda Colson
Pierpaolo Peruzzi
Adam Kibel
Nobuhiko Hata
Lillian Tsai
Yin Hung
Robert Packard
Oliver Jonas
Brigham and Women's Hospital · USMassachusetts General Hospital · US

Funding

Image Guided Therapy Center - Ultrasound-based sensor system for the monitoring of COVID-19 patientsP41EB015898 · NIBIB · BRIGHAM AND WOMEN'S HOSPITAL · PI TEMPANY, CLARE M · 2012 to 2021
$18.9M
TRD 3 - Enabling Technologies for Intraprocedural GuidanceP41EB028741 · NIBIB · BRIGHAM AND WOMEN'S HOSPITAL · PI Stephan E Maier · 2021 to 2026
$10.7M
Evaluation of an implantable microdevice for rapid cancer drug screening directly in T cell lymphoma patientsR37CA252312 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI LAROCCA, CECILIA · 2020 to 2025
$4.0M
Pilot study of an implantable microdevice to test multiple drug responses in prostate cancer patientsR01CA232174 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI HATA, NOBUHIKO, JONAS, OLIVER · 2019 to 2023
$3.4M
Physician Assistance Technology in Image-guided Robotic Intervention of ProstateR01EB030539 · NIBIB · BRIGHAM AND WOMEN'S HOSPITAL · PI HATA, NOBUHIKO, ZHANG, HAICHONG · 2021 to 2024
$2.7M
Implantable microdevices with integrated optical imaging for high-throughput in situ tumor response and drug sensitivity measurementR37CA224144 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI JONAS, OLIVER · 2018 to 2023
$2.4M
Harnessing Artificial MicroRNA Clusters Against Glioblastoma Epigenetic Plasticity and Resistance to TherapyR01NS116144 · NINDS · BRIGHAM AND WOMEN'S HOSPITAL · PI PERUZZI, PIER PAOLO · 2020 to 2025
$2.1M
Characterization of a microRNA network regulating glioblastoma epigenetics, cell reprogramming and DNA repairK08NS101091 · NINDS · BRIGHAM AND WOMEN'S HOSPITAL · PI PERUZZI, PIER PAOLO · 2017 to 2021
$992k
The roles of anti-apoptotic proteins BCL-XL and MCL1 in mediating survival of high-grade serous ovarian cancer following drug-induced DNA damageK08CA237871 · NCI · DANA-FARBER CANCER INST · PI STOVER, ELIZABETH HARMON · 2019 to 2023
$921k
Clinical Evaluation of an Implantable Lab-in-a-patient microdevice that measures in-situ response to therapies in advanced ovarian cancerR21CA216796 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI JONAS, OLIVER · 2018 to 2020
$399k
NCI NIH HHS K08 CA237871NCI NIH HHS R01 CA232174NCI NIH HHS R21 CA216796NCI NIH HHS R37 CA224144NCI NIH HHS R37 CA252312NIBIB NIH HHS P41 EB015898NIBIB NIH HHS P41 EB028741NIBIB NIH HHS R01 EB030539NINDS NIH HHS K08 NS101091NINDS NIH HHS R01 NS116144
6 · The paper itself

Abstract

objectiveThe purpose of this article is to report the translational process of an implantable microdevice platform with an emphasis on the technical and engineering adaptations for patient use, regulatory advances, and successful integration into clinical workflow.

methodsWe developed design adaptations for implantation and retrieval, established ongoing monitoring and testing, and facilitated regulatory advances that enabled the administration and examination of a large set of cancer therapies simultaneously in individual patients.

resultsSix applications for oncology studies have successfully proceeded to patient trials, with future applications in progress.

conclusionFirst-in-human translation required engineering design changes to enable implantation and retrieval that fit with existing clinical workflows, a regulatory strategy that enabled both delivery and response measurement of up to 20 agents in a single patient, and establishment of novel testing and quality control processes for a drug/device combination product without clear precedents. SIGNIFICANCE: This manuscript provides a real-world account and roadmap on how to advance from animal proof-of-concept into the clinic, confronting the question of how to use research to benefit patients.

Indexed as

NeoplasmsPharmaceutical PreparationsAnimalsDrug Delivery SystemsHumansProstheses and ImplantsWorkflowPharmaceutical Preparations

Identifiers

PMID34242160
PMCPMC8702455
OpenAlexW3178195615

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.