Katherine Nowak
Detroit, Michigan, 48202, United States
Location status: Recruiting
Location contact
Carlos Guerra, MD
CONTACT
Katherine Nowak, PhD
CONTACT
NCT Number: NCT05426928
Hyperthermic Intraperitoneal Chemotherapy (HIPEC) is a well-established alternative for patients with peritoneal surface malignancies. Although HIPEC has a predetermined protocol to manage body temperature, the resultant bladder and core-body temperatures are highly variable and unstable in clinical practice. Such results highlight an incomplete understanding of the thermodynamic processes during HIPEC in humans.
Previous clinical and animal investigations have studied abdominal hyperthermia, but a full human model incorporating patient variables, heat delivery, and the impact of the circulatory system and anesthesia in HIPEC has not been established.
This project seeks to develop and validate a computational thermodynamic model using prospective real-world data from humans undergoing HIPEC surgery. It is hypothesized that by incorporating patient, anesthetic, and perfusion-related variables in a thermodynamic model, the temperatures inside and outside the abdomen during HIPEC can be predicted.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Detroit, Michigan, 48202, United States
Location status: Recruiting
Carlos Guerra, MD
CONTACT
Katherine Nowak, PhD
CONTACT
Peritoneal surface malignancies are a group of cancers arising from rare primary or common secondary tumors. Regardless of the etiology, the prognosis is poor and only a few therapies have shown promising results. Hyperthermic Intraperitoneal Chemotherapy (HIPEC) is a well-established alternative for patients with these malignancies. Still, as many as 46% of patients recur early after treatment.
Although HIPEC has a predetermined protocol to manage body temperature, the resultant bladder and core-body temperatures are highly variable. Age, gender, body mass index, and type and duration of chemotherapy are key factors influencing the incidence and severity of bladder hyperthermia. While clinical and animal investigations have studied abdominal hyperthermia, a full human model incorporating patient variables, heat delivery, and the impact of the circulatory system and anesthesia in HIPEC has not been established.
To bridge this gap in knowledge, this project seeks to develop and validate a computational thermodynamic model using prospective real-world data from humans undergoing HIPEC surgery. It is hypothesized that by incorporating patient, anesthetic, and perfusion-related variables in a thermodynamic model, the temperatures inside and outside the abdomen during HIPEC can be predicted. By predicting temperature changes during HIPEC, clinicians can improve the safety and efficacy of therapeutic hyperthermia.
The hypothesis will be evaluated through two specific aims:
Specific aim 1: To develop a computational, thermodynamic model of intraabdominal hyperthermia for humans undergoing HIPEC. The rationale is that existing thermodynamic models are designed for non-anesthetized or hypothermic humans, implying the need of a new model with the conditions of a HIPEC treatment.
Specific aim 2: To validate our novel computational thermodynamic model using prospective real-world data from humans undergoing HIPEC surgery. Our rationale is that by using real-world data, the initial (SA1) computational model can be optimized and ultimately used to formulate individualized hyperthermia treatments.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All patients in this study will receive the same standard of care treatment for their HIPEC procedure. The only difference will be the use of additional temperature probes to collect more robust data regarding intraabdominal temperature, and the prospective collection of actual boundary conditions of the system.
Time frame: Duration of HIPEC procedure (2-4 hours)
Temperature values over time during a HIPEC treatment.
Time frame: Duration of HIPEC procedure (2-4 hours)
Temperature values over time during a HIPEC treatment.
Time frame: Duration of HIPEC procedure (2-4 hours)
Weighed calculation of the skin temperature values over time during a HIPEC treatment.
Time frame: Duration of HIPEC procedure (2-4 hours)
Temperature values over time during a HIPEC treatment.
Time frame: Duration of HIPEC procedure (2-4 hours)
Temperature values over time during a HIPEC treatment
Time frame: Duration of HIPEC procedure (2-4 hrs)
Temperature values over time during a HIPEC treatment
Time frame: Duration of HIPEC procedure (2-4 hours)
Temperature values over time during a HIPEC treatment
Time frame: Duration of HIPEC procedure (2-4 hours)
Flow values (mL/min) over time during a HIPEC treatment
Time frame: Duration of HIPEC procedure (2-4 hours)
Temperature values over time during a HIPEC treatment
Time frame: Duration of HIPEC procedure (2-4 hours)
Temperature values over time during a HIPEC treatment
Time frame: Duration of HIPEC procedure (2-4 hours)
Temperature values over time during a HIPEC treatment
Time frame: Preoperative, on average within 3 months prior to surgery.
3D-lab post-processing of preoperative CT scans.
Time frame: Preoperative, on average within 3 months prior to surgery.
3D-lab post-processing of preoperative CT scans.
Time frame: Preoperative, on average within 3 months prior to surgery.
3D-lab post-processing of preoperative CT scans.
Time frame: Duration of HIPEC procedure (2-4 hours)
Blood pressure values over time during a HIPEC treatment.
Time frame: Duration of HIPEC procedure (2-4 hours)
Heart rate values over time during a HIPEC treatment.
Time frame: Duration of HIPEC procedure (2-4 hours)
Cardiac output values over time during a HIPEC treatment.
Time frame: Duration of HIPEC procedure (2-4 hours)
Stroke volume variation values over time during a HIPEC treatment.
Time frame: Preoperative, obtained the day of surgery.
Determined by impedancemetry
Time frame: Preoperative, obtained the day of surgery.
Participant's weight
Time frame: Preoperative, obtained the day of surgery.
Participant's height
Contact information is provided by the study sponsor or research team.
Henry Ford Health System
Other
Development of a Computational, Thermodynamic Model of Intraabdominal Hyperthermia in Humans Undergoing HIPEC
Acronym: HIPEC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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