MDACC Study Summary 2003-0885

Study Summary
No. 2003-0885:.......Liver; Lung......Chaan Ng......Diagnostic Radiology

Study Summary Title



Study Summary Number:	2003-0885

Study Title:	Reproducibility of Functional and Structural Parameters from Dynamic Contrast Enhancement Magnetic Resonance Imaging (dceMRI) in Primary or Metastatic Lung and Liver Malignancies, and from Dynamic Contrast Enhancement Computed Tomography (dceCT) in Primary or Metastatic Lung Malignancies

Physician

New Patient Referral



Name:	Chaan Ng	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Diagnostic Radiology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-6759 Contact us about clinical trials

General Information



Disease Group:	Liver Lung	Supported By:	N/A

Phase of Study:	Phase I	Return Visit:	Each subject will need to return once to be scanned a second time between day 2-7.

Treatment Agents:	None	Home Care:	N/A

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this pilot clinical research study is to find out if blood flow measurements to tumors can be repeated identically using the scanning techniques of MRI and CT scans.

Study Objectives / Outcomes

This project will collect test-retest dceMRI and dceCT data in a setting relevant to Phase I oncology clinical trials. The data will be used to support the definition of a minimum magnitude of treatment-induced changes that can be considered an objective physiological vascular response. This information is useful for establishing proof of activity for angiogenesis inhibitors, a primary target for development of anti-cancer drugs.

Primary Objectives:

1. To determine the degree of reproducibility in perfusion parameters derived from dceMRI and dceCT, in lung and liver tumors.
2. To determine the differences in the reproducibility of perfusion parameters as derived from dceMRI and dceCT, in the evaluation of lung tumors.
3. To determine the degree of variability associated with data acquisition from two different clinical sites.

Secondary Objectives:

1. To identify sources of variability in the quantitation of perfusion parameters as measured by dceMRI and dceCT.
2. To compare the variability of functional measures with morphological assessments.

Study Status Information



Study Activation / Registration Date:	03/02/2004

IRB Review and Approval Date:	11/19/2003

Study Type:	Diagnostic

Recruitment Status:	Closed

Projected Accrual:	48

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Subjects must be at least 18 years old.

2) Subjects must have an ECOG performance score of 0-2.

3) Subjects must have adequate organ function as determined by reviewing medical records for the following criteria a. Bone marrow function (within 30 days of study day 1): 1. Absolute neutrophil count (ANC) > or = 1500 cells/mm^3 2. Platelets > or = 100,000 cells/mm^3 b. Renal function (within 14 days of study day 1): 1. Serum creatinine < or = 1.5 mg/dL or a calculated creatinine clearance of > or = 60 ml/min c. Liver function (within 30 days of study day 1): 1. Bilirubin < or = 1.5 mg/dL 2. AST (SGOT) and/or ALT (SGPT) < or = 5X ULN (upper limit of normal range)

4) Subjects must be diagnosed with primary liver or lung carcinomas or sarcomas, or metastases to these sites.

5) Index lesion selection criteria: Eligible subjects must have at least one primary or metastatic lung/liver malignancy.

6) Index lesion selection criteria: Must have at least one lesion located in the lung/liver that is greater than 3cm, and less than 7 cm, in transaxial plane.

7) Index lesion selection criteria: Lesions must be well-demarcated.

8) Index lesion selection criteria: The index lesion should demonstrate visible contrast enhancement on the most recent CT or MRI scan (i.e. not cysts).

9) Index lesion selection criteria: When there are multiple lesions, one lesion should be chosen as the index lesion. Other tumors in the scan volume should be considered of lesser importance.

10) Index lesion selection criteria: The index lesion should be the most enhancing tumor which meets all other criteria.

11) Index lesion selection criteria: The imaging acquisition volume should be centered on the index lesion.

12) Index lesion selection criteria: When possible, the index lesion should be fully encompassed by the imaging acquisition volume.

13) Index lesion selection criteria: Index lesions should be chosen to avoid motion, cardiac pulsation, and beam hardening artifact, particularly from vascular structures, extending into the tumor.

14) Index lesion selection criteria: The volume of interest defined in the baseline study should be used for subsequent studies.

15) For liver lesions: a. Liver lesions must be solid masses, and show no radiographic signs of calcification. 1 If not documented in medical records, these tests will be performed at screening visit. b. For liver lesions, the primary target lesion should be more than 1 cm from the diaphragm. c. Less that 60% of liver should be involved by tumor.

16) For lung lesions: a. Lung lesions must not be cavitating. b. The index lesion must be more than 1 cm cranial to the dome of the diaphragm. c. Paramediastinal lesions should be avoided. d. Pleural lesions are acceptable if they meet all other criteria. e. Lymphatic tissue is not to be used as target lesions in this protocol

Exclusion Criteria:

1) Chemotherapy/ biologic therapy/ endocrine therapy: Subjects may have received prior standard or investigational therapies for their primary disease, if discontinued for at least 4 weeks prior to start of study treatment.

2) Radiotherapy: Subjects may have received prior radiotherapy, if discontinued for at least 4 weeks prior to start of study treatment, and if not applied to the liver/lung index lesions being evaluated in this study.

3) Surgery: Subjects must have not received surgery for at least 30 days prior to day 1 on this study.

4) For liver lesions: Subjects with portal vein occlusion or ascites that requires regularly scheduled paracentesis.

5) Subjects who have a contraindication to undergo an MRI scan evaluation for reasons such as claustrophobia, presence of implanted devices or metallic foreign bodies.

6) Subjects with a known history of allergic reaction to iodine, iodinated contrast agent, and/or gadolinium.

7) Subjects with a previously known active infection, such as HIV, hepatitis B, or hepatitis C (no screening for seroconversion required).

8) Subjects with any mental disorder (e.g. hepatic encephalopathy) that would limit the understanding or rendering of informed consent and/or compromise compliance with the requirements of this protocol.

9) Female subjects who are pregnant or lactating.

10) Female subjects of childbearing potential unless they have a negative serum or urine pregnancy test within 3 days prior to start of study treatment.

Links

Registration Number: Not Registered