Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06518174
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-08
Brief Title:
A Novel Imaging Modality to Evaluate Radiation-Induced Uterine Injury
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Novel Imaging Modality to Evaluate Radiation-Induced Uterine Injury
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 initiation12 months is selected to increase the occurrence of uterine fibrosis The investigator will perform transabdominal standard B-mode and Doppler US SWE and pelvic MRI and characterize uterine parameters The B-mode and Doppler US will be referred to collectively as US This will provide essential information to design an intervention trial of a novel therapeutic approach to the treatment of radiation-induced uterine damage The overall objective of the study will be achieved through the following specific aims
Aim 1 Assess the feasibility of SWE and pelvic MRI to identify and characterize uterine fibrosis Hypothesis A grid map sampling of the uterus will indicate feasibility of SWE and pelvic MRI to detect and characterize uterine fibrosis
Approach SWE and MRI will be performed at time of study recruitment US procedures will be transabdominal When possible and with participant consent transvaginal US will also be performed MRI images will also be sampled from existing pretreatment studies performed as standard of care
Perform SWE and MRI sampling of the uterus from fundus to lower uterine segment at two locations each from the upper mid and lower thirds of the uterus six grid sample locations
Obtain five measurements at each location to evaluate for the presence and degree of fibrosis
1 Assess the relationship between SWE measurements in kiloPascals kPa and each MRI parameter among cases at the post-treatment timepoint
2 Assess the relationship between SWE measurements and each MRI parameter in kPa among controls at one random timepoint
3 Evaluate differences in kPa between cases and controls according to SWE at the post-treatment timepoint The imaging study will be considered feasible if at least 85 eg 1517 of all enrolled cases achieve the diagnosability criteria by SWE defined as having the interquartile range to median ratio IQRM of the measurements kPa 30 at any of the six locations
Aim 2 Characterize uterine parameters after PRT Hypothesis Patients treated with PRT for colorectalanal cancer will have decreased uterine volume and increased arterial resistive indices blood flow on US
Approach
2a Perform US and estimate uterine volumes and arterial resistance Use descriptive statistics to compare values to controls in the same age group
2b Perform MRI and describe changes in each parameter among cases between the pre- and post-treatment timepoints Assess changes in size of the uterus from baseline junctional zone anatomy endometrial thickness cervical length myometrial thickness T2 signal of the myometrium normalized for skeletal muscle signal acting as an internal control and enhancement features
Aim 1 Assess the feasibility of SWE and pelvic MRI to identify and characterize uterine fibrosis Hypothesis A grid map sampling of the uterus will indicate feasibility of SWE and pelvic MRI to detect and characterize uterine fibrosis
Approach SWE and MRI will be performed at time of study recruitment US procedures will be transabdominal When possible and with participant consent transvaginal US will also be performed MRI images will also be sampled from existing pretreatment studies performed as standard of care
Perform SWE and MRI sampling of the uterus from fundus to lower uterine segment at two locations each from the upper mid and lower thirds of the uterus six grid sample locations
Obtain five measurements at each location to evaluate for the presence and degree of fibrosis
1 Assess the relationship between SWE measurements in kiloPascals kPa and each MRI parameter among cases at the post-treatment timepoint
2 Assess the relationship between SWE measurements and each MRI parameter in kPa among controls at one random timepoint
3 Evaluate differences in kPa between cases and controls according to SWE at the post-treatment timepoint The imaging study will be considered feasible if at least 85 eg 1517 of all enrolled cases achieve the diagnosability criteria by SWE defined as having the interquartile range to median ratio IQRM of the measurements kPa 30 at any of the six locations
Aim 2 Characterize uterine parameters after PRT Hypothesis Patients treated with PRT for colorectalanal cancer will have decreased uterine volume and increased arterial resistive indices blood flow on US
Approach
2a Perform US and estimate uterine volumes and arterial resistance Use descriptive statistics to compare values to controls in the same age group
2b Perform MRI and describe changes in each parameter among cases between the pre- and post-treatment timepoints Assess changes in size of the uterus from baseline junctional zone anatomy endometrial thickness cervical length myometrial thickness T2 signal of the myometrium normalized for skeletal muscle signal acting as an internal control and enhancement features
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None