PET/MR for Staging Rectal Cancer Patients With and Without EMVI-MR

NCT ID: NCT02537340

Last Updated: 2020-06-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 104 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2019-05-31

Brief Summary

The hypothesis to be proven with this study is that the use of PET/MR on the initial staging of rectal cancers in patients with extramural vascular invasion detected by MR will detect more lesions than conventional work-up and will significantly impact on therapeutic decision, improving disease free and overall survival.

Detailed Description

The accurate staging of rectal cancer is essential to define therapy and for prognosis assessment. Imaging modalities usually provide useful information for pre-operative planning of primary tumour resection and may indicate the need of neoadjuvant treatment. It is recommended the use of magnetic resonance imaging (MRI) for local staging and computed tomography (CT) of chest, abdomen and pelvis for detection of distant metastasis. Patients with rectal cancer and vascular invasion might benefit from an intensive pre-operative staging in order to early detect distant metastasis, favouring a better therapeutic planning. There is no consensus regarding the use of PET/MR for initial staging of patients with rectal cancer. It has been shown that although changing pattern's in patients' stage, the use of PET/MR for colorectal cancers did not impact disease management. New studies are required for identifying the subgroup of patients with changes in the pre-operative MR that might benefit from the use of PET/MR for initial staging of rectal cancers.

Patients with rectal cancer will undergo pelvic MR, whole-body CT and whole-body PET/MR. According to the tumour characteristics on MR, there will be defined two group of patients: with EMVI-RM (group A) and without EMVI-MR (group B). The whole-body CT and PET/MR will be evaluated for the detection of loco-regional lymph nodes disease and distant metastasis. The total number of lesions and their respective sites will be recorded and compared for each method. The PET/MR management impact will be determined from the medical record or by direct contact with the treating clinician. The impact of PET/MR on management will be defined as high (the treatment modality or intent was changed), medium (the treatment modality or intent remained unchanged, although the method of treatment delivery or planned diagnostic procedure was changed), low (PET/MR results were consistent with planned management, and treatment modality or intent was unchanged), or none (the management plan was not changed, despite being inconsistent with the PET/MR stage-that is, PET/MR results were ignored). Overall survival will be used to evaluate prognostic significance. Clinical follow-up will be performed 3 monthly for 2 years. Imaging and, eventually biopsy, will be performed to evaluate symptoms or signs suggestive of residual or recurrent disease.

Conditions

Rectal Neoplasms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

EMVI-MR positive

Patients with primary rectal cancer and extramural vascular invasion detected by staging MR

No interventions assigned to this group

EMVI-MR negative

Patients with primary rectal cancer and without extramural vascular invasion detected by staging MR

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age > 18 years;
• No contraindication to MRI (eletromagnetic devices, claustrophobia);
• No contraindication to PET/MR (hyperglycemia, claustrophobia);
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

• Local resection of rectal tumor;
• Non-colorectal synchronic lesion;
• Previous treatment (chemo or radiation therapy) for rectal cancer;
• Renal insufficiency;
• Pregnancy, lactation or inadequate contraception
• Known allergy to contrast media (CT, MR or PET);
• Blood glucose level higher than 150 mg/dl.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: collaborator

Instituto do Cancer do Estado de São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Marcelo Araujo Queiroz

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlos Buchpiguel, MD, PhD

Role: STUDY_DIRECTOR

University of Sao Paulo

Locations

Instituto do Câncer do Estado de São Paulo

São Paulo, , Brazil

Countries

Brazil

References

Queiroz MA, Ortega CD, Ferreira FR, Capareli FC, Nahas SC, Cerri GG, Buchpiguel CA. Value of Primary Rectal Tumor PET/MRI in the Prediction of Synchronic Metastatic Disease. Mol Imaging Biol. 2022 Jun;24(3):453-463. doi: 10.1007/s11307-021-01674-1. Epub 2021 Nov 9.

Reference Type: DERIVED

PMID: 34755248 (View on PubMed)

Queiroz MA, Ortega CD, Ferreira FR, Nahas SC, Cerri GG, Buchpiguel CA. Diagnostic accuracy of FDG-PET/MRI versus pelvic MRI and thoracic and abdominal CT for detecting synchronous distant metastases in rectal cancer patients. Eur J Nucl Med Mol Imaging. 2021 Jan;48(1):186-195. doi: 10.1007/s00259-020-04911-x. Epub 2020 Jun 20.

Reference Type: DERIVED

PMID: 32561971 (View on PubMed)

Other Identifiers

NP796/15

Identifier Type: -

Identifier Source: org_study_id