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

Rectal Neoplasms Clinical Trial

Official title:

The Use of PET/MR for Initial Staging of Rectal Cancer Patients With Extramural Vascular Invasion Detected by MR (EMVI-MR)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02537340
• Other study ID #: NP796/15
• Status: Completed
• Start date: September 2016
• Est. completion date: May 2019

Study information

• Verified date: June 2020
• Source: Instituto do Cancer do Estado de São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: May 2019
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rectal Neoplasms

Locations

Country	Name	City	State
Brazil	Instituto do Câncer do Estado de São Paulo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Instituto do Cancer do Estado de São Paulo	GE Healthcare

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection rate	Number of metastatic lesions detected	12 months
Secondary	Clinical Impact	Measured by change in patient's therapy through questionnaire applied to referring physician	12 months
Secondary	Progression-free survival	Measured in terms of loco-regional or distant recurrence by 3 years.	36 months
Secondary	Overall survival	Measured in terms of death related to disease by 3 years.	36 months