PET/MRI as a Predictor of Response to Pre-op Chemoradiati... | NCT01751516

Studies
PET/MRI as a Predictor of Response to Pre-op Chemoradiation in Resectable Rectal Cancer: a Pilot Study

NCT01751516

Sponsor

UNC Lineberger Comprehensive Cancer Center

Status

Completed

Last Update Posted

Jan 29, 2021Actual

Enrollment

8Actual

Phase

Not provided

Conditions

Rectal Carcinoma

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012Actual

Primary Completion Date

Aug 2014Actual

Completion Date

Mar 4, 2018Actual

First Submitted Date

Dec 13, 2012

First Submission Date that Met QC Criteria

Dec 13, 2012

First Posted Date

Dec 18, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2021

Last Update Posted Date

Jan 29, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a single arm, single center pilot study of 40 patients with uT3N0 or uT1-3N+ rectal cancer receiving pre-operative chemoradiation. Subjects will undergo PET/MRI scans before and after surgery.

Detailed Description

The primary purpose of this study is to determine the negative predictive value of PET/MRI for determining pathological complete response from neoadjuvant chemoradiation.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Measure	Description	Time Frame
Negative post-chemoradiation PET/MRI scan, as correlated with surgical pathology		4-8 weeks post-chemoradiation

Measure	Description	Time Frame
Recurrence-free survival		5 years
Disease-specific survival		5 years
Overall survival

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Low-lying, low- to moderate-risk pathologically-confirmed rectal cancer (stage uT3n) or uT1-3N+
Negative workup for distant disease
> 18 years of age
Pre-treatment workup completed including:
history and physical
CT or MRI of the abdomen and pelvis
endoscopic tumor evaluation (biopsy, blood work to assess CEA and hematopoietic, renal and liver function)
if female of child-bearing age, negative pregnancy test
Recommendation to undergo preoperative concurrent chemoradiation, as determined by the treating physician
Informed consent reviewed and signed

Exclusion Criteria:

Not deemed a candidate for preoperative chemoradiation for medical reasons, such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus or cardiac disease
Hemoglobin ≤ 10.0 g/dL (transfusion allowed to achieve or maintain levels)
ANC ≤ 1,500/cubic mm³
Platelet count ≤ 100,000/mm³
ALT and AST ≥ 2.5 times upper level of normal (ULN)
Alkaline phosphatase ≥ 2.5 times ULN
Total bilirubin ≥ 1.5 times ULN
Creatinine clearance < 50 mL/min
Creatinine ≥ 1.5 times ULN
Not deemed a candidate for concurrent preoperative chemoradiation for social reasons, such as psychiatric illness
Not deemed a surgical candidate
Currently active second malignancy, except non-melanoma skin cancer, non-invasive bladder cancer, low risk adenocarcinoma of the prostate and carcinoma in situ of the cervix
Previous pelvic radiation therapy
History of severe reaction to gadolinium
Inability to tolerate MRI (e.g., inability to lie flat for > 1 hour)
Presence of a pacemaker, intracranial aneurysm clip, bladder stimulator, cochlear implant or metal near eyes
Body Mass Index (BMI) > 35
Pregnant or lactating female

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

UNC Hospitals

Sampling Method

Non-Probability Sample

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms