Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-24 @ 11:17 PM
NCT ID:
NCT00820456
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00820456
Study Brief:
Protocol Section:
NCT00820456