Interest of PET-MRI in the Evaluation of the Response After Neoadjuvant Treatment of Locally Advanced Rectal Adenocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Description of the correlation between the PET-MRI changes after neo-adjuvant treatment and the histological response after surgery in terms of MRI criteria.
研究概览
简要总结
With 50 patients included, this trial would be the largest pilot study evaluating the value of MRI PET in locally advanced rectal cancer. On the other hand, it would be the only pilot study performing several MRI PET during neoadjuvant treatment. Presumably, the response assessed at the 2nd MRI PET (before cycle 4 or induction chemotherapy) would be predictive of the overall response at the end of neoadjuvant treatment. Then, it would be possible to predict precociously the tumor response.
详细描述
The management of localized rectal cancer is done in two phases. The first phase, medical, combines a possible first chemotherapy, followed by a concomitant chemoradiotherapy. The second phase, 6 to 8 weeks later, consists of surgery of the rectum.
Magnetic resonance imaging (MRI) of the pelvis allows staging of the tumor and its possible lymph node extensions. MRI can also be used to assess tumor response after the first phase of treatment and before surgery. But MRI of the pelvis is partially imperfect.
PET-MRI is an examination that combines MRI with an injection of [18 F]fluorodeoxyglucose (18F-FDG). It is known to be more sensitive in assessing tumor stage and lymph node extensions compared to MRI and more sensitive in assessing tumor response before surgery.
The aim of this study is to determine predictive parameters for response to the first phase of treatment by accurately identifying the characteristics of tumors that have responded or not to treatment with chemotherapy and chemoradiotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) 0 to 2
- •Histologically proven rectal cancer
- •clinical tumor classification (cT) : cT3 - cT4 or all T / N+ / M0
- •Tumor resectable or considered resectable after chemoradiotherapy
- •Decision chemotherapy followed by neoadjuvant chemoradiotherapy decided at the organ Multidisciplinary Meeting
- •Absence of distant metastases
- •Adequate contraception for women of childbearing potential
- •Free, signed and informed consent
- •For women of childbearing potential : negative pregnancy test
排除标准
- •Subject with Uncontrolled diabetes
- •Contraindication to surgery
- •Contraindication to MRI
- •Contraindication to PET scan
- •Contraindication to chemotherapy
- •History of pelvic radiotherapy
- •History of major co-morbidity that may prevent treatment and no active infection (HIV or chronic hepatitis B or C)
- •Colloid (mucinous) adenocarcinoma
- •Presence of distant metastases
- •Contraindication to 5-FluoroUracil (FU), oxaliplatin or irinotecan
- •History of known Gilbert's disease
- •Patient with known UGT1A1 genotype
- •Known Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency
- •Medical history of chronic diarrhea or inflammatory disease of the colon or rectum
- •Medical history of angina or myocardial infarction.
- •Active progressive infection or any other serious medical condition that could compromise the administration of the treatment
- •Other concurrent cancer, or medical history of cancer other than treated in situ cervical carcinoma or basal cell carcinoma or squamous cell carcinoma
- •Patient enrolled in another clinical trial testing an investigational agent
- •Pregnant or breastfeeding woman
- •Persons deprived of their freedom or under guardianship or incapable of giving consent
- •Any psychological, familial, sociological or geographic condition that may interfere with the study protocol or follow-up schedule
研究组 & 干预措施
Adult population with rectal cancer
干预措施: PET-MRI (Other)
结局指标
主要结局
Description of the correlation between the PET-MRI changes after neo-adjuvant treatment and the histological response after surgery in terms of MRI criteria.
时间窗: At the surgery
MRI criteria will be measured with the Apparent Diffusion Coefficient (ADC) values that will be determined on the 4 PET-MRI scans.
Description of the correlation between the PET-MRI changes after neo-adjuvant treatment and the histological response after surgery in terms of metabolic criteria.
时间窗: At the surgery
The purpose of this study is to determine predictive parameters for response to the first phase of treatment by accurately identifying the characteristics of tumors that have responded or not to chemotherapy and chemoradiotherapy. Metabolic criteria will be measured with the SUVmax values that will be determined on the 4 PET-MRI scans.
Description of the correlation between the PET-MRI changes after neo-adjuvant treatment and the histological response after surgery in terms of anatomopathological criteria.
时间窗: At the surgery
Anatomopathological criteria will be measured with the histopathological response to treatment which will be defined according to the tumor regression grade (TRG)
次要结局
- Propose standardized criteria to differentiate responders from non-responders(Data record throughout the study, up to 28 months)
- Comparison of the first PET-MRI staging with standard of care imaging, namely pelvic MRI in terms of tumor volumes(At the PET MRI pretherapy (= PET MRI 1))
- Comparison of the first PET-MRI staging with standard of care imaging, namely pelvic MRI in terms of SUVmax values(At the PET MRI pretherapy (= PET MRI 1))
- Description of the specific PET-MRI responses to neoadjuvant radiochemotherapy in terms of delta ADC values(At the 4th PET (PET4), up to 28 months)
- Comparison of the first PET-MRI staging with standard of care imaging, namely pelvic MRI in terms of ADC values(At the PET MRI pretherapy (= PET MRI 1))
- Description of the specific PET-MRI responses at mid-treatment of the neoadjuvant chemotherapy in terms of delta ADC values(At the 2nd PET (PET2), up to 28 months)
- Description of the specific PET-MRI responses to neoadjuvant chemotherapy in terms of delta SUVmax values(At the 3rd PET (PET3), up to 28 months)
- Description of the specific PET-MRI responses at mid-treatment of the neoadjuvant chemotherapy in terms of delta tumor volume(At the 2nd PET (PET2), up to 28 months)
- Description of the specific PET-MRI responses to neoadjuvant chemotherapy in terms of delta tumor volume(At the 3rd PET (PET3), up to 28 months)
- Description of the specific PET-MRI responses to neoadjuvant radiochemotherapy in terms of delta tumor volume(At the 4th PET (PET4), up to 28 months)
- Description of the specific PET-MRI responses at mid-treatment of the neoadjuvant chemotherapy in terms of delta SUVmax values(At the 2nd PET (PET2), up to 28 months)
- Description of the specific PET-MRI responses to neoadjuvant chemotherapy in terms of delta ADC values(At the 3rd PET (PET3), up to 28 months)
- Description of the specific PET-MRI responses to neoadjuvant radiochemotherapy in terms of delta SUVmax values(At the 4th PET (PET4), up to 28 months)