Imaging Techniques for Uterine Injury

Overseen By Guluzar Turan, MD

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Hysterectomy, Pregnancy

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

22 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this pilot study is to assess the ability of a new imaging modality, shear-wave-elastography (SWE) and magnetic resonance imaging (MRI) to identify radiation-induced uterine injury (RIUI). The investigator will recruit female patients treated for colorectal or anal cancer at 15 to 39 years with ≥ 50 Gy pelvic radiation (PRT) at least 12 months prior to study initiation.

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

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Novel Imaging Modality, Shear-Wave Elastography, SWE, Magnetic Resonance Imaging, MRI for uterine injury?

Research shows that shear wave elastography (SWE) and magnetic resonance imaging (MRI) are effective in detecting changes in tissue stiffness, which can help diagnose and treat various uterine conditions like fibroids and adenomyosis. These imaging techniques are non-invasive and provide valuable information for early diagnosis and treatment evaluation. ^{1 2 3 4 5}

Is shear wave elastography (SWE) safe for use in humans?

Shear wave elastography (SWE) has been used in studies to assess uterine and breast conditions, and these studies suggest it is generally safe for human use. ^{1 3 6 7 8}

How does this treatment differ from other treatments for uterine injury?

This treatment uses shear wave elastography (SWE), a novel imaging technique that measures tissue elasticity to detect early uterine injury, which is different from traditional imaging methods that may not provide such detailed information on tissue properties. ^{1 3 6 9 10}

Research Team

Leslie Appiah, MD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for women aged 15-39 who were treated for colorectal or anal cancer with at least 50 Gy of pelvic radiation therapy (PRT) a year or more ago. It aims to detect uterine damage from the treatment.

Inclusion Criteria

I am female.

I am between 15 and 40 years old.

I have received PRT treatment at UCH.

Exclusion Criteria

Patients that are currently pregnant

I had a hysterectomy due to gynecologic cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Assessment

Participants undergo imaging assessments including SWE, MRI, and ultrasound to evaluate uterine parameters and fibrosis

Single visit

1 visit (in-person)

Follow-up

Participants are monitored for changes in uterine parameters and fibrosis over time

Up to six months

Treatment Details

Interventions

• Novel Imaging Modality

Trial Overview The study tests new imaging techniques, specifically shear-wave-elastography (SWE) and magnetic resonance imaging (MRI), to identify radiation-induced injuries in the uterus that may have resulted from cancer treatments.

Participant Groups

Group I: Cases undergone PRT Active Control 1 Intervention

Patients (or their legal guardians) who opt for participating in this pilot study will be consented and enrolled in the study. Patients will then be scheduled for a single study visit at the University of Colorado Hospital (UCH) that includes: 1. Pregnancy test 2. Pelvic MRI without and with contrast (if patient consents to contrast) 3. Transabdominal pelvic ultrasound using standard B-mode and Doppler US, SWE 4. Optional transvaginal ultrasound using standard B-mode and Doppler US, SWE

Group II: Controls Placebo Group 1 Intervention

Controls (or their legal guardians) who opt for participating in this pilot study will be consented and enrolled in the study. Patients will then be scheduled for a single study visit at the University of Colorado Hospital (UCH) that includes: 1. Pregnancy test 2. Pelvic MRI without and with contrast (if patient consents to contrast) 3. Transabdominal pelvic ultrasound using standard B-mode and Doppler US, SWE 4. Optional transvaginal ultrasound using standard B-mode and Doppler US, SWE

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Findings from Research

In a pilot study involving six subjects with uterine leiomyomas, in vivo magnetic resonance elastography (MRE) successfully measured the elasticity of the tumors, achieving appropriate phase signal-to-noise ratios in all cases.

The elasticity of the leiomyomas varied significantly, ranging from 3.95 to 6.68 kPa, indicating that MRE can effectively assess the mechanical properties of these tumors, although further research is needed to enhance the technique and its clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance elastography of uterine leiomyomas: a feasibility study. Stewart, EA., Taran, FA., Chen, J., et al.[2021]

3D multifrequency MR elastography (3DMMRE) successfully created detailed maps of the viscoelastic properties of uterine tissue, revealing that the uterine corpus is more elastic than the cervix, while both have similar viscosity.

The study found that the stiffness of the endometrium and myometrium significantly decreases during the menstrual cycle, with the myometrium showing lower elasticity in the secretory phase compared to the proliferative phase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo high-resolution magnetic resonance elastography of the uterine corpus and cervix. Jiang, X., Asbach, P., Streitberger, KJ., et al.[2021]

Shear wave elastography (SWE) effectively detects early damage to the endometrium after artificial abortions, showing that the elasticity of the endometrium increases with the number of abortions, indicating potential harm.

The study found that endometrial thickness was significantly lower in women who had undergone three or more abortions compared to those with fewer or no abortions, suggesting that SWE may provide earlier insights into endometrial health than traditional thickness measurements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of early damage of endometrium after artificial abortion by shear wave elastography. Jiao, Y., Xue, N., Zou, C., et al.[2020]

Ultrasound elastography (USE) is a non-invasive and repeatable technique that can detect changes in tissue stiffness, which may indicate various pathological conditions in the uterus, such as fibroids and adenomyosis, earlier than traditional clinical symptoms.

USE, particularly shear wave elastography, shows promise in improving the diagnosis and treatment of uterine tumors and managing conditions like preterm birth and intrauterine insemination, making it a valuable tool in obstetrics and gynecology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in the clinical application of ultrasound elastography in uterine imaging. Wang, XL., Lin, S., Lyu, GR.[2022]

In a pilot study involving 12 women with symptomatic uterine leiomyomas, magnetic resonance elastography (MRE) was used to measure the stiffness of the tumors, revealing a median stiffness of 4.9 kPa.

The study found that the stiffness of leiomyomas increased with the percentage of extracellular components, suggesting that MRE could help characterize these tumors based on their microscopic composition, although further research is needed to confirm its diagnostic utility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Uterine leiomyomas: correlation between histologic composition and stiffness via magnetic resonance elastography - a Pilot Study. Obrzut, M., Obrzut, B., Zmuda, M., et al.[2021]

Transvaginal ultrasound shear wave elastography (TVUS SWE) showed higher shear wave velocities (SWVs) in women with uterine adenomyosis and leiomyomas compared to those without any myometrial abnormalities, indicating its potential for assessing uterine conditions.

However, TVUS SWE could not differentiate between adenomyosis and leiomyomas, suggesting that while it may help identify the presence of myometrial pathology, it is not effective for distinguishing between these two specific conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transvaginal Ultrasound Shear Wave Elastography for the Evaluation of Benign Uterine Pathologies: A Prospective Pilot Study. Zhang, M., Wasnik, AP., Masch, WR., et al.[2019]

The updated 2D shear wave elastography (SWE) algorithm significantly improves the sensitivity for detecting breast lesions, increasing from 45% to 100% compared to the standard algorithm, while still maintaining a high negative predictive value of 100%.

This new algorithm also helps to reduce false-negative results associated with 'soft' cancer artifacts, allowing for more accurate characterization of breast lesions and the potential to downgrade all BI-RADS 4 lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved Breast 2D SWE Algorithm to Eliminate False-Negative Cases. Barr, RG., Engel, A., Kim, S., et al.[2023]

Transvaginal real-time shear wave elastography (SWE) was evaluated in 140 female patients with confirmed endometrial lesions, showing significant differences in elasticity measurements between normal endometrium and various types of endometrial lesions, particularly cancer.

The study found that Emax (the maximum elasticity measurement) had the highest diagnostic value for distinguishing endometrial cancer from normal tissue, suggesting that SWE could be a valuable auxiliary tool in diagnosing and differentiating endometrial cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transvaginal Real-Time Shear Wave Elastography in the Diagnosis of Endometrial Lesions. Du, YY., Yan, XJ., Guo, YJ., et al.[2022]

Real-time shear-wave elastography (SWE) is a promising technique for measuring testicular stiffness, showing feasibility in a study of 66 male volunteers aged 20 to 86, with significant differences in stiffness based on the testicular region measured.

The study found that the upper pole of the testis had lower stiffness compared to the center and lower pole, indicating that measurement location is crucial for accurate assessment, which could aid in diagnosing conditions like scrotal masses or male infertility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shear-wave elastography of the testis in the healthy man - determination of standard values. Trottmann, M., Marcon, J., D'Anastasi, M., et al.[2022]

Shear wave elastography (SWE) demonstrated superior diagnostic value compared to magnetic resonance imaging (MRI) in differentiating between benign and malignant breast masses, with a sensitivity of 93.02% and specificity of 93.75%.

In a study of 80 patients, SWE showed a high diagnostic agreement with histopathological results (Kappa coefficient of 0.87), while MRI had a lower agreement (Kappa coefficient of 0.42), indicating that SWE is more reliable for assessing breast lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differentiating solid breast masses: comparison of the diagnostic efficacy of shear wave elastography and magnetic resonance imaging. Farghadani, M., Barikbin, R., Rezaei, MH., et al.[2021]

References

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

Magnetic resonance elastography of uterine leiomyomas: a feasibility study. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

In vivo high-resolution magnetic resonance elastography of the uterine corpus and cervix. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Assessment of early damage of endometrium after artificial abortion by shear wave elastography. [2020]

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

Advances in the clinical application of ultrasound elastography in uterine imaging. [2022]

5. Poland pubmed.ncbi.nlm.nih.gov

Uterine leiomyomas: correlation between histologic composition and stiffness via magnetic resonance elastography - a Pilot Study. [2021]

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

Transvaginal Ultrasound Shear Wave Elastography for the Evaluation of Benign Uterine Pathologies: A Prospective Pilot Study. [2019]

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

Improved Breast 2D SWE Algorithm to Eliminate False-Negative Cases. [2023]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Transvaginal Real-Time Shear Wave Elastography in the Diagnosis of Endometrial Lesions. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Shear-wave elastography of the testis in the healthy man - determination of standard values. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Differentiating solid breast masses: comparison of the diagnostic efficacy of shear wave elastography and magnetic resonance imaging. [2021]