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Dosimetry Group for Gynecologic Cancers

Phase 2
Waitlist Available
Led By Steve Cho, MD
Research Sponsored by University of Wisconsin, Madison
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 up to 1 day
Awards & highlights

Study Summary

This trial is testing how well PSMA PET and MR Imaging can detect cancer cells in people with gynecologic cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 day
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Diagnostic Accuracy
Secondary outcome measures
Biodistribution of PSMA Measured by SUVmax in Cancer Tissue
Biodistribution of PSMA Measured by SUVmax in Normal Tissue
Radiodosimetry of PSMA
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Patient GroupExperimental Treatment1 Intervention
The patient group will consist of women with suspected gynecological cancers who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive standard of care PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=40
Group II: Healthy Control Non-Dosimetry GroupExperimental Treatment1 Intervention
The control group will consists of women with no imaging evidence of gynecological cancer, who are undergoing hysterectomy and salpingo-oophorectomy. Women will receive PSMA-based 18F-DCFPyL tracer and PET/MR imaging. n=6
Group III: Dosimetry GroupExperimental Treatment1 Intervention
Women with or without suspected gynecological cancer. Women will receive PSMA-based 18F-DCFPyL tracer and PET/CT imaging, PET/MR imaging as needed. n=6

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,182 Previous Clinical Trials
3,167,372 Total Patients Enrolled
1 Trials studying Gynecologic Cancers
75 Patients Enrolled for Gynecologic Cancers
Steve Cho, MDPrincipal InvestigatorUniversity of Wisconsin, Madison
4 Previous Clinical Trials
24 Total Patients Enrolled
Elizabeth Sadowski, MDPrincipal InvestigatorUniversity of Wisconsin, Madison
1 Previous Clinical Trials
1,340 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients who are under the age of 80 eligible for this research opportunity?

"The eligibility requirements for this study allow people that are aged 18 or older and no more than 99 years old to participate."

Answered by AI

Can people with the qualifying health conditions participate in this research project at this time?

"The listing on clinicaltrials.gov does show that this research is looking for participants right now. This specific trial was originally posted on August 10th, 2017 and updated most recently on May 11th, 2022. They need 52 individuals total, but only have 1 site at the moment."

Answered by AI

Is this a common treatment that has been tested before in other medical trials?

"There are a total of 19 clinical trials currently underway that are focusing on this treatment. Of those, 0 are in Phase 3. Many of the studies related to this topic are based out of Baltimore, but there 28 research centres across the United States working on these investigations."

Answered by AI

What is the conventional use for this medication?

"This treatment can be effective for patients with increased prostate specific antigen levels, suspected metastasis, and positive results from positron emission tomography."

Answered by AI

Has this medication been federally regulated?

"At Power, we gave this treatment a safety rating of 2. This is because it is only in Phase 2 trials, meaning that while there has been some data supporting its safety, there is no evidence yet that the treatment is effective."

Answered by AI

Who does this study target as its participants?

"This particular trial is testing a new intervention on 52 individuals that have gynecologic cancers. The ages of these patients range from 18 to 99 years old. There are a few requirements for participants which are as follows: being scheduled for or having already undergone a hysterectomy and/or salpingo-oophorectomy, being female, and being over the age of 18. Some participants may also have suspected gynecological cancer while others do not."

Answered by AI

What is the ceiling for potential participants in this research project?

"That is accurate. The information available on clinicaltrials.gov affirms that the research team is still looking for patients to enrol in this clinical trial. This particular study was originally posted on 8/10/2017 and was last edited on 5/11/2022; it is hoping to have 52 people participate at 1 site."

Answered by AI
~2 spots leftby Apr 2025