NCT05772481

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 16, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

May 19, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2025

Completed
Last Updated

August 23, 2023

Status Verified

August 1, 2023

Enrollment Period

2.3 years

First QC Date

February 8, 2023

Last Update Submit

August 21, 2023

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (13)

  • 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)

  • 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 tumor volume

    At the 2nd PET (PET2), 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

  • +8 more secondary outcomes

Study Arms (1)

Adult population with rectal cancer

Other: PET-MRI

Interventions

PET-MRIOTHER

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.

Adult population with rectal cancer

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient with histologically proven rectal cancer with an indication for induction chemotherapy followed by neoadjuvant chemoradiotherapy

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de cancérologie Strasbourg Europe

Strasbourg, 67033, France

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Manon VOEGELIN

CONTACT

+33 6 68 33 95 23promotion-rc@icans.eu

Claire VIT

CONTACT

+ 33 6 68 33 95 23promotion-rc@icans.eu

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2023

First Posted

March 16, 2023

Study Start

May 19, 2023

Primary Completion

September 19, 2025

Study Completion

September 19, 2025

Last Updated

August 23, 2023

Record last verified: 2023-08

Locations

FR(1)