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Angle Interleaved Projection Reconstruction With K-Space Weighted Image Reconstruction for Dynamic Contrast MRI of Cancer Therapy Response


N/A
18 Years
N/A
Open (Enrolling)
Both
Colorectal Neoplasm, Hepatic Neoplasm

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Trial Information

Angle Interleaved Projection Reconstruction With K-Space Weighted Image Reconstruction for Dynamic Contrast MRI of Cancer Therapy Response


This study will investigate the use of projection reconstruction dynamic contrast-enhanced
MRI (DCE-MRI) as a surrogate marker of tumor vascularity in patients treated with the
antiangiogenic agent bevacizumab. DCE-MRI is gaining popularity as a method to assess the
functional response of tumors to agents targeting the vascular endothelial growth factor
(VGEF) pathways. DCE-MRI measurements have been proposed as a non-invasive measure of both
tumor biologic activity and (in the case of antivascular therapy) early response to
treatment. A number of phase I and II studies demonstrate the ability for DCE-MRI to detect
perfusion changes associated with tumor biologic response to vascularly targeted agents. It
has been suggested that pre-treatment DCE-MRI might identify tumors with high intrinsic
perfusion and that these tumors will be more likely to respond to antivascular-based
therapies. However, the current use of DCE-MRI in clinical settings is challenging.
Trade-offs between spatial coverage, time, and spatial resolution make this technique
difficult to implement in human studies and may limit its reliability. The use of projection
reconstruction-based acquisition can mitigate the need for these trade-offs and can
simultaneously provide high temporal and spatial resolution data for DCE-MRI analysis.


Arm A:

Inclusion Criteria:



- Participants must be >18 years old;

- Participants must have an ECOG performance status of 0-1;

- Participants must not be pregnant or breastfeeding;

- Participants must have prior histological documentation of adenocarcinoma of the
colon or rectum;

- Participants must be commencing chemotherapy with FOLFOX plus bevacizumab;

- Participants must not have had prior exposure to bevacizumab. Prior systemic
chemotherapy with other agents is allowed. The last dose of systemic chemotherapy
must have been > 3 months prior to study entry;

- Participants with prior radiotherapy or other prior local therapy to the liver
(radioablation therapy, chemoembolic therapy) are acceptable. They must be at least
4 weeks past the last administration of such therapy;

- Participants must be at least 4 weeks past any major surgery, including surgery to
the liver;

- Participants with prior malignancies other than colon cancer are allowed, provided
they have been treated with curative intent, and have no evidence of recurrence of
that malignancy;

- Participants must have a life expectancy of greater than 3 months;

- Participants must have the ability to understand and the willingness to sign a
written informed consent form.

Arm B: Inclusion Criteria

- Participants must be >18 years old;

- Participants must have an ECOG performance status of 0-1;

- Participants must not be pregnant or breastfeeding;

- Participants must have prior histological documentation of any types of cancer with
metastasis to the liver (see Imaging Criteria below);

- Participants must be projected to be within a stable treatment condition prior to and
between scans (see section 4.3 for definition of stable treatment condition);

- Participants must be at least 4 weeks past any major surgery, including surgery to
the liver;

- Participants must have a life expectancy of greater than 3 months;

- Participants must have the ability to understand and the willingness to sign a
written informed consent form.

Imaging Criteria:

- Participants must have at least one hepatic lesion greater than or equal to 3 cm in
maximal diameter on cross sectional imaging study (CT or MRI) performed within 4
weeks prior to study enrollment;

- Participants must have at least one qualifying liver lesion (i.e. one greater than or
equal to 3 cm) that has been confirmed metastatic adenocarcinoma of the colon or
rectum based on one of the following criteria:

- Histologic (FNA or core biopsy) proof of malignancy compatible with metastasis
from a colorectal carcinoma; OR

- Demonstration of imaging features of tumor metastasis to the liver, including at
least one of the following:

1. evidence of heterogeneous enhancement or central tumor necrosis by CT or
MRI;

2. previously demonstrated interval enlargement of the lesion by >25% in the
longest diameter;

3. PET image demonstrating metabolic activity characteristic of malignancy
(FDG uptake greater than that of background liver).

- For participants who have undergone local hepatic surgical, radiation, ablative, or
embolic therapy, the date of qualifying imaging study(ies) or qualifying biopsy must
be at least 30 days after the last instance of such local therapy. Furthermore,
cross-sectional imaging performed at least 30 days after such local therapy must
demonstrate an area of residual viable tumor (as judged by enhancing tissue following
contrast administration) with longest diameter ≥ 3cm in at least one cross-sectional
axis.

Arms A and B (Unless Otherwise Indicated): Exclusion Criteria:

- Patients with contraindication to MRI, including:

1. Contraindicated metallic device, including pacemaker, non-MRI compatible
aneurysm clip, other non-MRI compatible mechanical and/or electrical device, or
metallic fragments;

2. Patients with severe claustrophobia (patients with milder forms of
claustrophobia that can be successfully allayed with oral anxiolytic therapy are
allowed);

- Patients with contraindication to gadolinium, including:

a) Hypersensitivity to gadolinium-containing MR contrast agents;

- Severe impaired renal function with estimated glomerular filtration rate <30
mL/min/1.73 m2 and/or on dialysis;

- Patients with severely compromised pulmonary, cardiovascular, or mental status.
Patients must not have severe congestive heart failure (defined as New York Heart
Association Class II or greater);

- For Arm A only: Any other major medical illness that, in the investigator's opinion,
would: (1) prevent administration or completion of institution's standard of care
FOLFOX/bevacizumab therapy; (2) prevent administration or completion of
protocol-specified imaging; and/or (3) interfere with follow-up.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

To determine the reproducibility of DCE-MRI measures of tumor Ktrans, kep, and ve for colorectal metastases to the liver (Arm A) and any cancer metastatic to the liver (Arm B), using projection interleaved back-projection DCE-MRI techniques.

Outcome Time Frame:

Three (3) DCE-MRI scans (two separate pre-treatment and one post-treatment DCE-MRI exams [post-treatment defined as after the first cycle of chemotherapy with bevacizumab])

Safety Issue:

No

Principal Investigator

Mark Rosen, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pennsylvania

Authority:

United States: Institutional Review Board

Study ID:

ACRIN PA 4002

NCT ID:

NCT00820456

Start Date:

April 2008

Completion Date:

Related Keywords:

  • Colorectal Neoplasm
  • Hepatic Neoplasm
  • colorectal cancer
  • colorectal neoplasm
  • colorectal neoplasms
  • metastasis
  • metastases
  • liver
  • hepatic metastasis
  • liver metastasis
  • perfusion imaging
  • MRI
  • magnetic resonance imaging
  • dynamic contrast enhanced MRI
  • dynamic contrast enhanced magnetic resonance imaging
  • Neoplasms
  • Colorectal Neoplasms
  • Liver Neoplasms

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
University of Pittsburgh Medical CenterPittsburgh, Pennsylvania  15213
Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Thomas Jefferson University HospitalPhiladelphia, Pennsylvania  19131
Penn State University Hershey Medical CenterHershey, Pennsylvania  17033