ivWatch for Cancer

Overseen By Andrew Storer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Roswell Park Cancer Institute

Must be taking: Vesicant agents

Disqualifiers: Bruised, scarred, tattooed, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 1 year

2395 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called ivWatch to determine if it can detect IV leaks before they cause harm. Leaks during chemotherapy or similar treatments can damage surrounding tissue if not caught early. The ivWatch device aims to detect these leaks faster than the human eye. The trial seeks cancer patients who require an IV for chemotherapy or similar treatments. Participants should not have any skin issues or tattoos near the IV site. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance safety during chemotherapy treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on patients who need a peripheral IV for certain types of medications, but it doesn't mention any requirements to stop other medications.

What prior data suggests that the ivWatch device is safe for use in detecting PIV catheter infiltrations?

Research has shown that the ivWatch device is generally safe for patients. In a study of 2,254 infusions monitored with ivWatch, the device prevented 122 cases of fluid leaking from the vein into surrounding tissue, which could have caused harm. This demonstrates the device's ability to detect leaks early and potentially prevent damage. However, it should not be used during an MRI scan, as it is not safe in that environment. Overall, the device is well-tolerated when used as intended. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for cancer, which typically involves chemotherapy and radiation that target cancer cells directly, ivWatch is a medical device designed to enhance the safety and effectiveness of these treatments. ivWatch continuously monitors the infusion site to detect any leaks or complications early on, potentially preventing damage to surrounding tissues and ensuring that chemotherapy is delivered precisely where it needs to go. Researchers are excited about ivWatch because it could improve patient safety and the overall effectiveness of cancer treatments by reducing the risk of infusion-related complications.

What evidence suggests that the ivWatch device is effective for detecting PIV catheter infiltration?

Research has shown that the ivWatch device effectively detects when IV fluids leak from a vein into nearby tissue, a problem known as infiltration. A study in an infusion unit found that ivWatch identified more cases of infiltration than expected, demonstrating its potential to catch leaks early. Early detection is crucial because it helps prevent tissue damage that can occur when medication leaks outside the vein. In this trial, participants will use the ivWatch device during their scheduled chemotherapy sessions, highlighting its promise in protecting patients receiving IV therapies. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for cancer patients who are receiving treatment through a peripheral intravenous (PIV) catheter. It's designed to test if the ivWatch device can detect leaks of IV fluid into surrounding tissue, which could prevent damage caused by medication extravasation.

Inclusion Criteria

I need a special IV for strong medication like chemotherapy.

PIV must be inserted

Participant (or legal representative) must understand the nature of this study and verbally consent with the Research Study Information Sheet prior to receiving any study related procedure

Exclusion Criteria

Patients who are on 'light precautions'

Not for use in power injectors

Not for use on mediports, implanted ports, IVAD, central lines, PICC lines

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients utilize ivWatch device at time of already scheduled chemotherapy on study

Up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ivWatch

Trial Overview

The ivWatch device is being tested to see if it can spot infiltration at the site where an IV is inserted faster than nurses can by just looking. This could help in preventing tissue damage from drugs leaking out of veins.

How Is the Trial Designed?

Group I: Medical Device Usage Experimental Treatment 1 Intervention

Patients utilize ivWatch device at time of already scheduled chemotherapy on study

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Published Research Related to This Trial

In a study of 50 patients with locally advanced rectal cancer, intravoxel incoherent motion (IVIM) imaging showed significant increases in apparent diffusion coefficient (ADC) and diffusion coefficient (D) values after neoadjuvant chemoradiation (nCRT), indicating its potential to assess treatment response.

The study found that changes in ADC and D values were significantly correlated with patient responses to nCRT, with the percentage change in D (∆%D) being particularly effective in distinguishing patients with a pathological complete response (pCR) from those without.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

3.0 T MRI IVIM-DWI for predicting the efficacy of neoadjuvant chemoradiation for locally advanced rectal cancer. Hu, H., Jiang, H., Wang, S., et al.[2021]

Intravoxel incoherent motion (IVIM) imaging can help predict early responses to chemoradiotherapy (CRT) in cervical cancer, as shown in a study of 17 patients with cervical squamous cell carcinoma.

Patients who achieved complete remission (CR) showed significantly higher percentage changes in IVIM parameters compared to those who did not achieve CR, suggesting that IVIM could be a valuable tool in assessing treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting Early Response to Chemoradiotherapy for Uterine Cervical Cancer Using Intravoxel Incoherent Motion MR Imaging. Kato, H., Esaki, K., Yamaguchi, T., et al.[2020]

In a study of 45 cervical cancer patients, the pre-treatment perfusion fraction (f) measured using intravoxel incoherent motion (IVIM) MRI was significantly higher in patients who had a partial response to concurrent chemoradiotherapy (CCRT) compared to those with stable disease or disease progression, indicating its potential as a predictive biomarker for treatment response.

The study demonstrated good repeatability in tumor delineation and IVIM parameters, suggesting that these imaging techniques can reliably assess changes in tumor characteristics before and after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between IVIM parameters and treatment response in locally advanced squamous cell cervical cancer treated by chemoradiotherapy. Perucho, JAU., Wang, M., Vardhanabhuti, V., et al.[2021]

Using six b-values for intravoxel incoherent motion (IVIM) imaging in cervical cancer patients allows for a significant reduction in scan time (from 436 seconds to 198 seconds) while maintaining accuracy in parameter estimation, with less than 5% error rates.

For simplified IVIM modeling, only three b-values are needed, but this approach may compromise the ability to distinguish between different cancer types, indicating a trade-off between efficiency and diagnostic detail.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

B-Value Optimization in the Estimation of Intravoxel Incoherent Motion Parameters in Patients with Cervical Cancer. Perucho, JAU., Chang, HCC., Vardhanabhuti, V., et al.[2020]

In a study involving 21 patients with advanced cervical cancer undergoing concurrent chemo-radiotherapy (CCRT), IVIM MR imaging was found to be effective in monitoring early treatment responses, showing significant changes in diffusion metrics over time.

The apparent diffusion coefficient (ADC) and diffusion coefficient (D) values increased throughout the treatment, while the perfusion fraction (f) showed a significant rise during the first 2 weeks, indicating that IVIM imaging can serve as an early surrogate marker for treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating early response of cervical cancer under concurrent chemo-radiotherapy by intravoxel incoherent motion MR imaging. Zhu, L., Zhu, L., Shi, H., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8862432/

Comparing ivWatch biosensor to standard care to identify ...

The effectiveness of ivWatch, in comparison to clinical observation, in decreasing injury severity is unknown. The present study aims to ...

2.

ivwatch.com

ivwatch.com/wp-content/uploads/2024/04/British-Journal-of-Nursing-ivWatch-Clinical-Study_April-2024-8pp-Web-Lic-HRes.pdf

under-recognised complications of intravenous therapy

The ivWatch study was a great success for the infusion unit. The results showed a higher-than-expected infiltration rate within the infusion unit which was due ...

3.

trialx.com

trialx.com/clinical-trials/listings/293832/ivwatch-in-prevention-of-extravasation-of-vesicants-in-an-oncology-setting/

ivWatch in Prevention of Extravasation of Vesicants ...

Evaluate the feasibility of using the ivWatch device to detect extravasations of peripheral vesicants given in an adult oncology ambulatory ...

4.

ivwatch.com

ivwatch.com/wp-content/uploads/2025/01/BJN_Extravasation-and-Infiltration-Indentifying-best-practeces-improving.pdf

EXTRAVASATION & INFILTRATION

The ivWatch study was a great success for the infusion unit. The results showed a higher-than-expected infiltration rate within the infusion unit which was due ...

5.

withpower.com

withpower.com/trial/phase-neoplasms-4-2023-b2c04

ivWatch for Cancer

The ivWatch treatment is unique because it uses intravoxel incoherent motion (IVIM) imaging, which helps predict early responses to chemoradiotherapy in cancer ...

6.

ivwatch.com

ivwatch.com/wp-content/uploads/2023/03/ivWatch_User_Manual_ML-1001030_Rev04.pdf

User Manual

The ivWatch Patient Monitor, Extension Module, Patient Cable, and SmartTouch Sensor pose a safe- ty hazard if brought into the MRI environment. The Sensor ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04064229

ivWatch Sensor: Device Validation for Infiltrated Tissues

It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...