Interest of PET-MRI in the Evaluation of the Response After Neoadjuvant Treatment of Locally Advanced Rectal Adenocarcinoma

Rectal Cancer Clinical Trial

— TEPIREC  

Official title:

Interest of PET-MRI in the Evaluation of the Response After Neoadjuvant Treatment of Locally Advanced Rectal Adenocarcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05772481
• Other study ID #: 2022-007
• Status: Recruiting
• Start date: May 19, 2023
• Est. completion date: September 19, 2025

Study information

• Verified date: August 2023
• Source: Institut de cancérologie Strasbourg Europe
• Contact: Manon VOEGELIN
• Phone: +33 6 68 33 95 23
• Email: promotion-rc[@]icans.eu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 19, 2025
• Est. primary completion date: September 19, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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
• Adequate hematologic function
• Adequate liver function
• Free, signed and informed consent
• For women of childbearing potential : negative pregnancy test

Exclusion Criteria:

• 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)
• Hypofractionated radiotherapy according to the Swedish protocol (25 Gy in 5 fractions)
• 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

Related Conditions & MeSH terms

• Adenocarcinoma
• Rectal Cancer

Intervention

Other:
• PET-MRI
Each patient will have a pre-treatment PET-MRI (PET-MRI 1) within 21 days before the start of treatment. Induction chemotherapy may be performed at another center than the investigating center. After 3 cycles of induction chemotherapy and before the 4th cycle, a second PET MRI (PET MRI 2) will be performed. In patients who have received less than 3 cycles of induction chemotherapy, this mid-therapy PET-MRI will not be performed. A 3rd PET-MRI will be performed prior to radiation therapy (PET-MRI 3). A final MRI PET (MRI PET 4) will take place before surgery. A total of 4 PET MRI scans will be performed.

Locations

Country	Name	City	State
France	Institut de cancérologie Strasbourg Europe	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Institut de cancérologie Strasbourg Europe

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Description of the correlation between the PET-MRI changes after neo-adjuvant treatment and the histological response after surgery in terms of metabolic criteria.	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.	At the surgery
Primary	Description of the correlation between the PET-MRI changes after neo-adjuvant treatment and the histological response after surgery in terms of MRI criteria.	MRI criteria will be measured with the Apparent Diffusion Coefficient (ADC) values that will be determined on the 4 PET-MRI scans.	At the surgery
Primary	Description of the correlation between the PET-MRI changes after neo-adjuvant treatment and the histological response after surgery in terms of anatomopathological criteria.	Anatomopathological criteria will be measured with the histopathological response to treatment which will be defined according to the tumor regression grade (TRG)	At the surgery
Secondary	Comparison of the first PET-MRI staging with standard of care imaging, namely pelvic MRI in terms of tumor volumes	Record of tumor volumes on MRI PET 1	At the PET MRI pretherapy (= PET MRI 1)
Secondary	Comparison of the first PET-MRI staging with standard of care imaging, namely pelvic MRI in terms of SUVmax values	Record of SUVmax on MRI PET 1	At the PET MRI pretherapy (= PET MRI 1)
Secondary	Comparison of the first PET-MRI staging with standard of care imaging, namely pelvic MRI in terms of ADC values	Record of ADC on MRI PET 1	At the PET MRI pretherapy (= PET MRI 1)
Secondary	Description of the specific PET-MRI responses at mid-treatment of the neoadjuvant chemotherapy in terms of delta tumor volume	Record of delta tumor volume, compared to baseline (PET MRI 1)	At the 2nd PET (PET2), up to 28 months
Secondary	Description of the specific PET-MRI responses at mid-treatment of the neoadjuvant chemotherapy in terms of delta SUVmax values	Record of delta SUVmax, compared to baseline (PET MRI 1)	At the 2nd PET (PET2), up to 28 months
Secondary	Description of the specific PET-MRI responses at mid-treatment of the neoadjuvant chemotherapy in terms of delta ADC values	Record of delta ADC, compared to baseline (PET MRI 1)	At the 2nd PET (PET2), up to 28 months
Secondary	Description of the specific PET-MRI responses to neoadjuvant chemotherapy in terms of delta tumor volume	Record of delta tumor volume, compared to baseline (PET MRI 1)	At the 3rd PET (PET3), up to 28 months
Secondary	Description of the specific PET-MRI responses to neoadjuvant chemotherapy in terms of delta SUVmax values	Record of delta SUVmax, compared to baseline (PET MRI 1)	At the 3rd PET (PET3), up to 28 months
Secondary	Description of the specific PET-MRI responses to neoadjuvant chemotherapy in terms of delta ADC values	Record of delta ADC, compared to baseline (PET MRI 1)	At the 3rd PET (PET3), up to 28 months
Secondary	Description of the specific PET-MRI responses to neoadjuvant radiochemotherapy in terms of delta tumor volume	Record of delta tumor volume, compared to PET3	At the 4th PET (PET4), up to 28 months
Secondary	Description of the specific PET-MRI responses to neoadjuvant radiochemotherapy in terms of delta SUVmax values	Record of delta SUVmax, compared to PET3	At the 4th PET (PET4), up to 28 months
Secondary	Description of the specific PET-MRI responses to neoadjuvant radiochemotherapy in terms of delta ADC values	Record of delta ADC, compared to PET3	At the 4th PET (PET4), up to 28 months
Secondary	Propose standardized criteria to differentiate responders from non-responders	Record of clinical and iconographic data predictive of good response to treatment	Data record throughout the study, up to 28 months