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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Being evaluated for a known or suspected breast tumor (must present with either a mammographic abnormality 10mm or larger or a mammographically occult but palpable abnormality of the breast)
Non-pregnant, non-lactating females 18 years of age or older (must agree to use an appropriate and effective method of birth control during the study and for 2 weeks after study)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing a new imaging tool to see if it can detect breast cancer.
Who is the study for?
This trial is for non-pregnant women over 18 with suspected or known breast tumors, scheduled for a biopsy. They must not be breastfeeding, agree to birth control during the study and two weeks after, and have signed consent. Excluded are those in recent trials, had certain biopsies or indium agents recently, have serious health issues including kidney/liver problems or severe allergies to trial drugs.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of a medical imaging agent called 111In-DAC used alongside planar and SPECT imaging techniques to detect breast cancer in patients who are already scheduled for tumor biopsy or surgery.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to components of the imaging agent (111In-DAC), which could range from mild allergy symptoms to more severe anaphylaxis. Kidney damage is also a concern if there's prior susceptibility.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am being checked for a breast tumor, visible on mammogram or felt by touch.
Select...
I am a woman over 18, not pregnant or breastfeeding, and will use birth control during and after the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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Who is running the clinical trial?
CopharosLead Sponsor
1 Previous Clinical Trials
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am being checked for a breast tumor, visible on mammogram or felt by touch.I do not have a severe illness, kidney or liver issues, or a weak immune system.I have not received an indium agent in the last 30 days.I have not taken any kidney-damaging drugs in the last 2 weeks.I had a biopsy within the last 4 days.I am scheduled for a biopsy or surgery to remove a breast tumor.I cannot stay still during scans.I am a woman over 18, not pregnant or breastfeeding, and will use birth control during and after the study.
Research Study Groups:
This trial has the following groups: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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What risks have been associated with this treatment protocol?
"As this is an early-stage trial, with minimal data supporting its efficacy and safety, the treatment has been assigned a score of 1."
Answered by AI
Does this clinical trial have any age restrictions, particularly for younger participants?
"This clinical trial seeks participants between ages 18 and 65. However, there are 74 trials designed for those under the age of majority and 2505 specifically targeting senior citizens."
Answered by AI
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