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Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET Scan for Cancer
N/A
Waitlist Available
Led By Jeffrey Wong
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 and 3 months post study drug infusion
Awards & highlights
No Placebo-Only Group
Summary
This trial uses a radioactive antibody to help detect cancer cells in patients with high levels of a protein called CEA. PET scans may help find and diagnose cancer that may not be detected by other methods.
Who is the study for?
This trial is for adults with certain types of cancer that produce a marker called CEA. They must have completed any previous treatments at least 2 weeks before, agree to use contraception, and not be pregnant or breastfeeding. People with uncontrolled illnesses or allergies to similar drugs are excluded.
What is being tested?
The study tests a diagnostic procedure using Copper Cu 64 anti-CEA monoclonal antibody M5A PET scans to detect cancers expressing the CEA marker more effectively than standard methods.
What are the potential side effects?
Potential side effects may include allergic reactions related to the copper Cu 64 anti-CEA monoclonal antibody M5A compound. Specific side effects are not listed but could relate to immune responses due to exposure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1 and 3 months post study drug infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 and 3 months post study drug infusion
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Tumor Uptake of 64Cu-DOTA-hT4.66-M5A at Day 1
Tumor Uptake of 64Cu-DOTA-hT4.66-M5A at Day 2
Secondary study objectives
Number of Participants With Human Anti-human Antibody (HAHA) Positive Response to 64Cu Labeled M5A Antibody
The Average Increase of Tumor-to-blood (T:B) Ratio From Day 1 to Day 2
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Diagnostic (copper Cu 64 anti-CEA monoclonal antibody M5A PET)Experimental Treatment5 Interventions
Patients receive copper Cu 64 anti-CEA monoclonal antibody M5A IV on day 0 and then undergo PET on day 1 and day 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
positron emission tomography
2010
Completed Phase 2
~1370
radionuclide imaging
2006
Completed Phase 1
~1120
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
602 Previous Clinical Trials
1,923,560 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,981 Total Patients Enrolled
Jeffrey WongPrincipal InvestigatorCity of Hope Medical Center
2 Previous Clinical Trials
17 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had allergic reactions to similar drugs or substances as 64Cu-M5A.I am not pregnant and will stop breastfeeding if treated with 54Cu-m5A.I do not have any uncontrolled illnesses or active infections.I haven't had chemotherapy or radiation in the last 2 weeks.I have recent (within 2 months) CT scans and blood tests.I can understand and am willing to sign the consent form.I have been exposed to certain mouse or human/mouse antibodies and have developed an antibody response.I finished any cancer treatments like chemotherapy or radiotherapy at least 2 weeks ago.My tumor produces CEA, or I have colorectal cancer.I had a detectable cancer site before starting treatment and may now be in remission.My cancer type was confirmed by a biopsy and reviewed by City of Hope's Pathology Department.
Research Study Groups:
This trial has the following groups:- Group 1: Diagnostic (copper Cu 64 anti-CEA monoclonal antibody M5A PET)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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