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Rectal NeoplasmsNCT07269912

Application of Multimodal MRI in Histological Grading and Prognostic Assessment of Rectal Cancer

An observational study of Rectal Neoplasms and Prognosis, run by Sichuan Cancer Hospital and Research Institute.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

Rectal cancer (RC) is among the most prevalent gastrointestinal cancers [1], characterized by significant tumor heterogeneity [2]. Neoadjuvant chemoradiotherapy followed by total mesorectal excision is a standard treatment for locally advanced rectal cancer [3]. Read more about this study

Who is it for?
Any age
Conditions the study is for
Rectal Neoplasms, Prognosis
What is being tested?
intravoxel incoherent motion magnetic resonance imaging
How many people
400 participants
Where
No sites listed yet
Study dates
1 Nov 2027to 1 Nov 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: 400 patients diagnosed with rectal cancer from the sichuan cancer hospital were consecutively recruited in this study

Who may be able to join

  • (1) patients underwent preoperative abdominal pelvic IVIM-MRI examination; (2) patients underwent surgical resection within 2 weeks after IVIM-MRI examination; (3) complete postoperative pathological data, including LVI status.

Who cannot join

  • (1) radiotherapy or chemotherapy before surgery; (2) preoperative metastatic disease; (3) poor image quality; (4) incomplete clinical data.

About this study

Official title: Sub-region Analysis Based on Intravoxel Incoherent Motion MRI for Preoperative Prediction of Lymphovascular Invasion and Prognosis in Rectal Cancer

Rectal cancer (RC) is among the most prevalent gastrointestinal cancers [1], characterized by significant tumor heterogeneity [2]. Neoadjuvant chemoradiotherapy followed by total mesorectal excision is a standard treatment for locally advanced rectal cancer [3]. Although the locoregional recurrence rate has decreased due to this treatment, distant metachronous metastases still occur in over 20-30% of cases [4,5]. The varying biological characteristics of rectal cancer may result in different treatment responses and prognoses [6]. Patients who are diagnosed with the same tumor-node-metastasis (TNM) stage of RC frequently exhibit vastly different clinical outcomes, despite receiving the same therapeutic interventions [7]. While the TNM staging system remains the predominantly used framework for directing treatment choices and forecasting prognosis, it is crucial to take into account additional pathological elements, such as tumor budding, lymphovascular invasion (LVI), perineural invasion, and extramural venous invasion [8-10]. A recent investigation has highlighted that LVI, rather than the traditionally prioritized extent of tumor invasion, serves as a significant risk factor for metastasis in early-stage RC [11]. Patients exhibiting LVI+ demonstrate a considerably worse prognosis and overall survival when compared to those with LVI -. Identifying LVI before surgery is crucial for informing treatment strategies in RC [12]. LVI offers important information regarding the tumor's biological behavior and its likelihood of metastasizing, thus improving the precision of disease staging. This information enables clinicians to tailor treatment approaches, which helps prevent overtreatment in patients with LVI -. In cases where LVI is present, it may be essential to adopt more aggressive treatment methods, such as postoperative chemotherapy, radiotherapy, or more extensive surgical resections, to reduce the chances of recurrence and metastasis. In summary, LVI serves as a crucial prognostic factor, providing essential insights into the tumor's potential for metastasis and recurrence, which has significant clinical implications for predicting postoperative outcomes, including recurrence, metastasis, and disease-free survival. Therefore, a preoperative non-invasive assessment of LVI, particularly in patients with LVI +, may be instrumental in guiding clinical practice.

Conventional magnetic resonance imaging (MRI) is particularly effective in observing large blood vessels and has moderate sensitivity and high specificity to distinguish LVI [13]. However, it can noninvasively and accurately assess extramural vascular invasion with a diameter greater than 3 mm. In contrast, it is challenging to evaluate vascular invasion with a diameter less than 3 mm, as well as intramural vascular and lymphatic infiltration, due to the limitations in resolution [14,15]. In addition, pathological biopsy is the gold standard for preoperative diagnosis. However, this invasive approach may not reflect the LVI status of the entire tumor due to possible sample errors [16]. Therefore, effectively assessing LVI in RC via preoperative imaging remains a significant challenge.

Read more

Intravoxel incoherent motion (IVIM) is a functional imaging method that can display the diffuse movement of water molecules and blood flow, microcirculation perfusion, thereby improving the diagnostic accuracy of RC [17,18]. The IVIM model has the potential to identify perfusion effects using multiple b-value samples and biexponential curve fit analysis [19], which can lead to three parameters, namely the true diffusion coefficient (D), the pseudo-diffusion coefficient (D*), and the perfusion fraction (f). Li et al [20]. discovered that the D value obtained from IVIM of LVI+ patients was significantly higher than that of LVI- patients with RC, but only 42 patients were included in this study, making it more difficult to accurately assess the feasibility of IVIM. In another study, Kan et al [21]. revealed that the D value was helpful to assess the prognostic factor related to RC, while the AUC of the D value for evaluating LVI was only 0.646. Currently, studies utilizing conventional IVIM quantitative parameters have demonstrated a relatively low diagnostic efficiency in detecting LVI, with AUC values ranging from 0.629 to 0.646 [22,23].

Tumor heterogeneity has emerged as a significant biomarker for tumor staging and prognosis [24]. Sub-region analysis, an innovative imaging post-processing technique, has demonstrated its potential in exploring intratumor heterogeneity in recent years. Prior research has underscored the importance of sub-region analysis derived from either single-modality or multiparametric MRI in the investigation of intratumor heterogeneity in RC [25-27]. However, to our knowledge, the application of sub-region analysis based on IVIM-MRI to evaluate LVI status and prognosis in patients with RC has not been reported. Thus, this study aimed to assess the fe

Read the detailed description

Rectal cancer (RC) is among the most prevalent gastrointestinal cancers [1], characterized by significant tumor heterogeneity [2]. Neoadjuvant chemoradiotherapy followed by total mesorectal excision is a standard treatment for locally advanced rectal cancer [3]. Although the locoregional recurrence rate has decreased due to this treatment, distant metachronous metastases still occur in over 20-30% of cases [4,5]. The varying biological characteristics of rectal cancer may result in different treatment responses and prognoses [6]. Patients who are diagnosed with the same tumor-node-metastasis (TNM) stage of RC frequently exhibit vastly different clinical outcomes, despite receiving the same therapeutic interventions [7]. While the TNM staging system remains the predominantly used framework for directing treatment choices and forecasting prognosis, it is crucial to take into account additional pathological elements, such as tumor budding, lymphovascular invasion (LVI), perineural invasion, and extramural venous invasion [8-10]. A recent investigation has highlighted that LVI, rather than the traditionally prioritized extent of tumor invasion, serves as a significant risk factor for metastasis in early-stage RC [11]. Patients exhibiting LVI+ demonstrate a considerably worse prognosis and overall survival when compared to those with LVI -. Identifying LVI before surgery is crucial for informing treatment strategies in RC [12]. LVI offers important information regarding the tumor's biological behavior and its likelihood of metastasizing, thus improving the precision of disease staging. This information enables clinicians to tailor treatment approaches, which helps prevent overtreatment in patients with LVI -. In cases where LVI is present, it may be essential to adopt more aggressive treatment methods, such as postoperative chemotherapy, radiotherapy, or more extensive surgical resections, to reduce the chances of recurrence and metastasis. In summary, LVI serves as a crucial prognostic factor, providing essential insights into the tumor's potential for metastasis and recurrence, which has significant clinical implications for predicting postoperative outcomes, including recurrence, metastasis, and disease-free survival. Therefore, a preoperative non-invasive assessment of LVI, particularly in patients with LVI +, may be instrumental in guiding clinical practice.

Conventional magnetic resonance imaging (MRI) is particularly effective in observing large blood vessels and has moderate sensitivity and high specificity to distinguish LVI [13]. However, it can noninvasively and accurately assess extramural vascular invasion with a diameter greater than 3 mm. In contrast, it is challenging to evaluate vascular invasion with a diameter less than 3 mm, as well as intramural vascular and lymphatic infiltration, due to the limitations in resolution [14,15]. In addition, pathological biopsy is the gold standard for preoperative diagnosis. However, this invasive approach may not reflect the LVI status of the entire tumor due to possible sample errors [16]. Therefore, effectively assessing LVI in RC via preoperative imaging remains a significant challenge.

Intravoxel incoherent motion (IVIM) is a functional imaging method that can display the diffuse movement of water molecules and blood flow, microcirculation perfusion, thereby improving the diagnostic accuracy of RC [17,18]. The IVIM model has the potential to identify perfusion effects using multiple b-value samples and biexponential curve fit analysis [19], which can lead to three parameters, namely the true diffusion coefficient (D), the pseudo-diffusion coefficient (D*), and the perfusion fraction (f). Li et al [20]. discovered that the D value obtained from IVIM of LVI+ patients was significantly higher than that of LVI- patients with RC, but only 42 patients were included in this study, making it more difficult to accurately assess the feasibility of IVIM. In another study, Kan et al [21]. revealed that the D value was helpful to assess the prognostic factor related to RC, while the AUC of the D value for evaluating LVI was only 0.646. Currently, studies utilizing conventional IVIM quantitative parameters have demonstrated a relatively low diagnostic efficiency in detecting LVI, with AUC values ranging from 0.629 to 0.646 [22,23].

Tumor heterogeneity has emerged as a significant biomarker for tumor staging and prognosis [24]. Sub-region analysis, an innovative imaging post-processing technique, has demonstrated its potential in exploring intratumor heterogeneity in recent years. Prior research has underscored the importance of sub-region analysis derived from either single-modality or multiparametric MRI in the investigation of intratumor heterogeneity in RC [25-27]. However, to our knowledge, the application of sub-region analysis based on IVIM-MRI to evaluate LVI status and prognosis in patients with RC has not been reported. Thus, this study aimed to assess the feasibility of utilizing sub-region analysis based on IVIM MRI to predict LVI status and prognosis in patients with RC.

Being tested
intravoxel incoherent motion magnetic resonance imaging
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • intravoxel incoherent motion magnetic resonance imagingDiagnostic test

    intravoxel incoherent motion magnetic resonance imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. "Number of Participants with Local Recurrence and Metastasisas Assessed by MRI"

    Measured: From enrollment to the end of treatment at 2 years

  2. The time of local recurrence and metastasis was defined as the interval from surgery to the detection of local recurrence and/or metastasis. The primary endpoint of the study was a 2-year DFS.

    Measured: From enrollment to the end of treatment at 2 years

  3. Number of Participants with local recurrence and metastasis as Assessed by digital rectal examinations, CEA level, endoscopic examinations, and CT or MRI scans of the head, chest, and abdominopelvic cavity

    Measured: From enrollment to the end of treatment at 2 years"

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2025
  2. Study start1 Nov 2027 (estimated)
  3. Primary completion1 Nov 2027 (estimated)
  4. Study completion1 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07269912
Sponsor's protocol ID
SCCHEC-02-2024-049
Status last verified
Sep 2025
First submitted
26 Nov 2025
Last updated
8 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Rectal Neoplasms and Prognosis, run by Sichuan Cancer Hospital and Research Institute.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

"Number of Participants with Local Recurrence and Metastasisas Assessed by MRI" (time frame: From enrollment to the end of treatment at 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.

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