Clinical trial NCT06719414: Application of Amide Proton Transfer-weighted Imaging in Predicting Pathological Complete Response After Neoadjuvant Therapy of Rectal Cancer
Official title: A Multi-center Study on Amide Proton Transfer-weighted Imaging in Predicting Pathological Complete Response After Neoadjuvant Therapy of Rectal Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rectal Cancer
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Xinyi People's Hospital/Sixth Affiliated Hospital, Sun Yat-sen University Yuexi Hospital
First posted: 2024-12-05
Enrollment: 320
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with locally advanced rectal cancer treated with neoadjuvant therapy

Brief 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 amide proton transfer-weighted imaging as part of their regular MRI examination.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: the area under curve (AUC) of receiver operating characteristic (ROC) curves of models in prediction tumor response
timeFrame: From date of baseline MRI to date of preoperative MRI，within 12 months
Secondary outcomes:
measure: the specificity of models in prediction tumor response
timeFrame: From date of baseline MRI to date of preoperative MRI，within 12 months
measure: the sensitivity of models in prediction tumor response
timeFrame: From date of baseline MRI to date of preoperative MRI，within 12 months
measure: the positive predictive value of models in prediction tumor response
timeFrame: From date of baseline MRI to date of preoperative MRI，within 12 months
measure: the negative predictive value of models in prediction tumor response
timeFrame: From date of baseline MRI to date of preoperative MRI，within 12 months
measure: the accuracy of models in prediction tumor response
timeFrame: From date of baseline MRI to date of preoperative MRI，within 12 months
measure: disease-free survival and overall survival
timeFrame: 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
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sixth Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Maoming
country: China
facility: Xinyi People's Hospital
state: Guangdong
Study officials:
References: