Rectal CancerNCT06719414
Application of Amide Proton Transfer-Weighted Imaging in Predicting Pathological Complete Response After Neoadjuvant Therapy of Rectal Cancer
An observational study of Rectal Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University at 2 sites in China.
Trial summary
The goal of this observational study is to learn about the amide proton transfer-weighted imaging for rectal cancer response assessment after neoadjuvant therapy. The main question it aims to answer is: Does amide proton transfer-weighted imaging predict the cancer response before surgery? Participants will underwent… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rectal Cancer
- How many people
- 320 participants
- Where
- 2 sitesChina
- Study dates
- 22 Oct 2024to Dec 2028
- 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: Patients with locally advanced rectal cancer treated with neoadjuvant therapy
Who may be able to join
- Locally advanced rectal cancer(cT3-4, or cN+), resectable, histologically confirmed rectal adenocarcinoma
- Received neoadjuvant therapy before surgery
- Complete radical resection of rectal cancer and postoperative pathological examination
- Informed consent and signed the informed consent form
Who cannot join
- Poor image quality, such as severe artifacts
- Complicated with intestinal obstruction, intestinal perforation and other cases requiring surgical treatment
- The interval between preoperative MRI and surgery was more than 2 weeks
- Prior treatment for rectal cancer
- History of other malignant tumors
- Patients who cannot undergo MRI examination due to contraindications or relative contraindications
- Patients were lost to follow-up or voluntarily withdrew from the study due to adverse reactions or other reasons
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
Pieyi Xie, 86+13724071514, xiepy6@mail.sysu.edu.cn
- Not yet recruiting
Xinyi People's Hospital
Maoming, Guangdong
Xi Li, 86+18938380811
About this study
Official title: A Multi-center Study on Amide Proton Transfer-Weighted Imaging in Predicting Pathological Complete Response After Neoadjuvant Therapy of Rectal Cancer
The goal of this observational study is to learn about the amide proton transfer-weighted imaging for rectal cancer response assessment after neoadjuvant therapy. The main question it aims to answer is:
- Does amide proton transfer-weighted imaging predict the cancer response before surgery? Participants will underwent amide proton transfer-weighted imaging as part of their regular MRI examination.
- Conditions
- Rectal Cancer
- Medical subject headings
- Rectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
the area under curve (AUC) of receiver operating characteristic (ROC) curves of models in prediction tumor response
Measured: From date of baseline MRI to date of preoperative MRI，within 12 months
Secondary outcomes (6)
the specificity of models in prediction tumor response
Measured: From date of baseline MRI to date of preoperative MRI，within 12 months
the sensitivity of models in prediction tumor response
Measured: From date of baseline MRI to date of preoperative MRI，within 12 months
the positive predictive value of models in prediction tumor response
Measured: From date of baseline MRI to date of preoperative MRI，within 12 months
the negative predictive value of models in prediction tumor response
Measured: From date of baseline MRI to date of preoperative MRI，within 12 months
the accuracy of models in prediction tumor response
Measured: From date of baseline MRI to date of preoperative MRI，within 12 months
disease-free survival and overall survival
Measured: From date of enrollement until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start22 Oct 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Xinyi People's Hospital
- Responsible party
- Principal investigator, Peiyi Xie, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719414
- Sponsor's protocol ID
- 2024ZSLYEC-552
- Status last verified
- Jan 2026
- First submitted
- 27 Nov 2024
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Study on Amide Proton Transfer-Weighted Imaging in Predicting Pathological Complete Response After Neoadjuvant Therapy of Rectal Cancer
- ClinicalTrials.gov ID
- NCT06719414
- Acronym / sponsor ID
- 2024ZSLYEC-552
- Conditions
- Rectal Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Xinyi People's Hospital
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn about the amide proton transfer-weighted imaging for rectal cancer response assessment after neoadjuvant therapy. The main question it aims to answer is:
- Does amide proton transfer-weighted imaging predict the cancer response before surgery? Participants will underwent amide proton transfer-weighted imaging as part of their regular MRI examination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with locally advanced rectal cancer treated with neoadjuvant therapy
Key inclusion criteria (4 listed)
- Locally advanced rectal cancer(cT3-4, or cN+), resectable, histologically confirmed rectal adenocarcinoma
- Received neoadjuvant therapy before surgery
- Complete radical resection of rectal cancer and postoperative pathological examination
- Informed consent and signed the informed consent form
Key exclusion criteria (7 listed)
- Poor image quality, such as severe artifacts
- Complicated with intestinal obstruction, intestinal perforation and other cases requiring surgical treatment
- The interval between preoperative MRI and surgery was more than 2 weeks
- Prior treatment for rectal cancer
- History of other malignant tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the area under curve (AUC) of receiver operating characteristic (ROC) curves of models in prediction tumor response
Time frame: From date of baseline MRI to date of preoperative MRI，within 12 months
6 secondary outcomes
the specificity of models in prediction tumor response
Time frame: From date of baseline MRI to date of preoperative MRI，within 12 months
the sensitivity of models in prediction tumor response
Time frame: From date of baseline MRI to date of preoperative MRI，within 12 months
the positive predictive value of models in prediction tumor response
Time frame: From date of baseline MRI to date of preoperative MRI，within 12 months
the negative predictive value of models in prediction tumor response
Time frame: From date of baseline MRI to date of preoperative MRI，within 12 months
the accuracy of models in prediction tumor response
Time frame: From date of baseline MRI to date of preoperative MRI，within 12 months
disease-free survival and overall survival
Time frame: From date of enrollement until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University at 2 sites in China.
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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Peiyi Xie (86+13724071514, xiepy6@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the area under curve (AUC) of receiver operating characteristic (ROC) curves of models in prediction tumor response (time frame: From date of baseline MRI to date of preoperative MRI，within 12 months). 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 27 Jan 2026.