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

Trial Summary

What is the purpose of this trial?

This study aims to determine the feasibility of using the ivWatch (registered trademark) device to determine if there is an infiltration at the site of a peripheral intravenous (PIV) catheter. An infiltration is when the IV fluid leaks out of a vein and into the surrounding tissue. If medication starts leaking outside the vein, it can cause damage to the surrounding tissue. Using the ivWatch device may identify leaking fluid before the nurse is able to visually observe the signs or symptoms of the leaking fluid.

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.

How is the ivWatch treatment different from other treatments for cancer?

The ivWatch treatment is unique because it uses intravoxel incoherent motion (IVIM) imaging, which helps predict early responses to chemoradiotherapy in cancer patients. This imaging technique can provide additional information on how well a patient is responding to treatment, potentially allowing for more personalized and effective care. ^{1 2 3 4 5}

Eligibility Criteria

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

I am not receiving any harsh chemotherapy treatments.

Patients who are on 'light precautions'

I have skin problems where my IV is or will be placed.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

References

1. Japan pubmed.ncbi.nlm.nih.gov

Predicting Early Response to Chemoradiotherapy for Uterine Cervical Cancer Using Intravoxel Incoherent Motion MR Imaging. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

3.0 T MRI IVIM-DWI for predicting the efficacy of neoadjuvant chemoradiation for locally advanced rectal cancer. [2021]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

B-Value Optimization in the Estimation of Intravoxel Incoherent Motion Parameters in Patients with Cervical Cancer. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

Association between IVIM parameters and treatment response in locally advanced squamous cell cervical cancer treated by chemoradiotherapy. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Evaluating early response of cervical cancer under concurrent chemo-radiotherapy by intravoxel incoherent motion MR imaging. [2022]