Modalities for Healthy Subjects

Overseen By Sarah Kucker, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Oklahoma State University

Disqualifiers: Developmental delay, Other language exposure

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 weeks

212 Participants Needed

Trial Summary

Do I need to stop my child's current medications for the trial?

The trial protocol does not specify whether participants must stop taking their current medications.

What data supports the effectiveness of the treatment Modalities for Healthy Subjects?

The research on multimodality imaging systems suggests that combining different imaging techniques can improve diagnostics and therapeutic monitoring by integrating the strengths of each modality. This implies that the treatment modalities being studied may offer enhanced diagnostic and therapeutic capabilities by leveraging the benefits of both 2D and 3D imaging. ^{1 2 3 4 5}

Is the treatment generally safe for humans?

Gadolinium-based contrast agents, used in MRI scans, have been widely used for 30 years and are generally considered safe, though there have been reports of gadolinium remaining in the brain without known harmful effects. Some people may experience mild reactions, but serious adverse events are rare. ^{6 7 8 9 10}

What is the purpose of this trial?

The goal of this work is to address increasing concerns about young children's digital media exposure and language outcomes by testing how the times course of word learning unfolds in digital environments and the cascading impact of digital media on vocabulary outcomes. The findings will have important implications for understanding when and where optimal word learning from media can occur.

Eligibility Criteria

This trial is for healthy toddlers aged between 17 to 30 months. It's designed for those who primarily speak one language and have not been diagnosed with any developmental delays or disorders.

Inclusion Criteria

My child is between 17 and 30 months old.

Exclusion Criteria

You have been diagnosed with a delay or disorder in your development.

You are not fluent in the study's required language, and have been exposed to more than 25% of another language.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in tasks to test word learning and generalization abilities using digital media

4-6 weeks

Follow-up

Participants are monitored for vocabulary growth and retention after the tasks

4 weeks

Treatment Details

Interventions

• Modality - 2D-2D
• Modality - 2D-3D
• Modality - 3D-2D

Trial Overview The study explores how toddlers learn new words through different types of digital media exposure: from two-dimensional (2D) to two-dimensional, three-dimensional (3D) to two-dimensional, and two-dimensional to three-dimensional formats.

Participant Groups

Group I: 3D-2D Experimental Treatment 1 Intervention

Initial exposure to items in 3D, generalization in 2D

Group II: 2D-3D Experimental Treatment 1 Intervention

Initial exposure to items in 2D, generalization in 3D

Group III: 2D-2D Experimental Treatment 1 Intervention

Initial exposure to items in 2D, generalization in 2D

Group IV: 3D-3D Active Control 1 Intervention

All items presented in 3D form.

Who Is Running the Clinical Trial?

Oklahoma State University

Lead Sponsor

Trials

51

Recruited

8,600+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

Mn-doped Prussian blue nanoparticles (MnPB NPs) show strong potential for enhancing both imaging and treatment of tumors, demonstrating excellent performance in T1 and T2 weighted MRI and effective photothermal therapy due to their near-infrared absorbance.

The integration of multimodal imaging with chemodynamic therapy (CDT) and mild temperature photothermal therapy (PTT) using MnPB NPs significantly improves therapeutic efficacy, making them a promising tool for simultaneous diagnosis and treatment of tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mn doped Prussian blue nanoparticles for T1/T2 MR imaging, PA imaging and Fenton reaction enhanced mild temperature photothermal therapy of tumor. Tao, Q., He, G., Ye, S., et al.[2022]

Advanced imaging techniques in oncology have not been widely accepted for guiding treatment decisions or improving clinical trial efficiency due to insufficient evidence supporting their effectiveness.

The paper highlights the need for better study designs and statistical methods to evaluate advanced imaging, emphasizing that merely showing a correlation between imaging results and clinical outcomes is not enough to prove their utility in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond Correlations, Sensitivities, and Specificities: A Roadmap for Demonstrating Utility of Advanced Imaging in Oncology Treatment and Clinical Trial Design. Huang, EP., Lin, FI., Shankar, LK.[2019]

The study introduces a power calculation formula that helps determine the necessary number of subjects and acceptable registration error for imaging validation studies, which is crucial for accurately assessing novel imaging modalities.

Monte Carlo simulations confirmed that the derived models can predict study power and minimum detectable differences with high accuracy, providing a valuable tool for designing effective imaging studies, such as those for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of registration accuracy on imaging validation study design: A novel statistical power calculation. Gibson, E., Fenster, A., Ward, AD.[2019]

A study involving 228 triple-negative breast cancer (TNBC) patients developed a radiomics score from MRI features that significantly predicts disease-free survival (DFS), showing worse DFS associated with higher scores in both training and validation sets.

The combined clinicopathologic-radiomic (CCR) model outperformed traditional clinicopathologic models in predicting DFS, indicating that integrating MRI-based radiomic features can enhance prognostic accuracy for TNBC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI Radiomic Features: Association with Disease-Free Survival in Patients with Triple-Negative Breast Cancer. Kim, S., Kim, MJ., Kim, EK., et al.[2021]

Multimodality imaging systems combine different types of radiation to enhance diagnostic capabilities by leveraging the strengths of each imaging technique while minimizing their weaknesses.

These advanced imaging systems are already being used in clinical settings and research, providing improved diagnostics and therapeutic monitoring for better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodality in vivo imaging systems: twice the power or double the trouble? Cherry, SR.[2006]

In a study of 1334 cardiovascular magnetic resonance (CMR) procedures for patients with congenital heart disease, the overall incidence of adverse events (AEs) was low at 1.6%, with most being minor in severity.

The use of general anesthesia and the status of being an inpatient were identified as independent risk factors for experiencing AEs, particularly in the most critically ill patients, highlighting the need for careful monitoring in these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for adverse events during cardiovascular magnetic resonance in congenital heart disease. Dorfman, AL., Odegard, KC., Powell, AJ., et al.[2013]

In a study involving 17,767 patients across 45 European centers, only 30 acute adverse reactions (0.17%) were reported after administering gadolinium-based contrast agents during cardiac magnetic resonance imaging, all classified as mild.

The most common reactions included rashes, hives, nausea, and anxiety, with the incidence of adverse events being comparable to that seen in general radiology settings, indicating that the off-label use of these agents in CMR is safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute adverse reactions to gadolinium-based contrast agents in CMR: multicenter experience with 17,767 patients from the EuroCMR Registry. Bruder, O., Schneider, S., Nothnagel, D., et al.[2016]

In a study of 863 patients undergoing MRI with gadodiamide contrast, only 9 reported mild adverse events, all of which were from the group that was actively questioned about their experiences after the injection.

The results suggest that the frequency of reported adverse events is influenced by whether patients are actively asked about them, indicating that many mild reactions may go unreported without such inquiries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequency of acute adverse events to a non-ionic low-osmolar contrast medium: the effect of verbal interview. Thomsen, HS.[2019]

Gadolinium-based contrast agents (GBCAs) have been safely used for 30 years, providing significant clinical benefits, but recent studies have shown unexpected long-term retention of gadolinium in the brain, particularly with linear GBCAs compared to macrocyclic GBCAs.

While no clinical consequences of gadolinium presence in the brain have been confirmed, further research is essential to understand the potential toxicological effects and to refine the clinical use of GBCAs, similar to past adaptations made during the nephrogenic systemic fibrosis crisis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methodological Aspects for Preclinical Evaluation of Gadolinium Presence in Brain Tissue: Critical Appraisal and Suggestions for Harmonization-A Joint Initiative. Robert, P., Frenzel, T., Factor, C., et al.[2019]

In a study of 154,779 patients undergoing cardiac MRI, gadolinium-based contrast agents (GBCAs) were used in 94.2% of cases, with a significant shift towards macrocyclic agents following regulatory changes, which showed a favorable acute safety profile.

The overall rate of acute adverse events (AAEs) associated with GBCAs was low at 0.36%, with severe events occurring in only 0.03% of patients, indicating that GBCAs, particularly macrocyclic types, are generally safe for use in cardiac imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gadolinium-based Contrast Agents for Cardiac MRI: Use of Linear and Macrocyclic Agents with Associated Safety Profile from 154 779 European Patients. Uhlig, J., Al-Bourini, O., Salgado, R., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Mn doped Prussian blue nanoparticles for T1/T2 MR imaging, PA imaging and Fenton reaction enhanced mild temperature photothermal therapy of tumor. [2022]

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

Beyond Correlations, Sensitivities, and Specificities: A Roadmap for Demonstrating Utility of Advanced Imaging in Oncology Treatment and Clinical Trial Design. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

The impact of registration accuracy on imaging validation study design: A novel statistical power calculation. [2019]

4. England pubmed.ncbi.nlm.nih.gov

MRI Radiomic Features: Association with Disease-Free Survival in Patients with Triple-Negative Breast Cancer. [2021]

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

Multimodality in vivo imaging systems: twice the power or double the trouble? [2006]

6. England pubmed.ncbi.nlm.nih.gov

Risk factors for adverse events during cardiovascular magnetic resonance in congenital heart disease. [2013]

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

Acute adverse reactions to gadolinium-based contrast agents in CMR: multicenter experience with 17,767 patients from the EuroCMR Registry. [2016]

8. Denmark pubmed.ncbi.nlm.nih.gov

Frequency of acute adverse events to a non-ionic low-osmolar contrast medium: the effect of verbal interview. [2019]

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

Methodological Aspects for Preclinical Evaluation of Gadolinium Presence in Brain Tissue: Critical Appraisal and Suggestions for Harmonization-A Joint Initiative. [2019]

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

Gadolinium-based Contrast Agents for Cardiac MRI: Use of Linear and Macrocyclic Agents with Associated Safety Profile from 154 779 European Patients. [2022]