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A Non-Invasive Cervical Cancer Screening Modality: A Pilot Study

Abramson Cancer Center at Penn Medicine logo

Abramson Cancer Center at Penn Medicine

Status

Terminated

Conditions

Women With Abnormal Pap Smears

Treatments

Device: non-invasive multimodal imaging

Study type

Interventional

Funder types

Other

Identifiers

NCT02767726
UPCC 02815

Details and patient eligibility

About

Cervix cancer is a major global health concern. A way to screen and immediately treat precancerous lesions (Screen-and-Treat) is greatly needed. Developed by MobileOCT, polarized difference imaging and conventional imaging are used to identify suspicious lesions. We aim to compare this non-invasive method with colposcopy. Patients at the Dickens Clinic will have 3-5 minutes of non-invasive imaging before colposcopy. Pathology will be compared both to colposcopy impression versus MobileOCT.

Enrollment

4 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subjects capable of giving informed consent or have an acceptable surrogate capable of giving consent on subjects behalf.
  • Subjects are 18 years of age or older
  • Subjects are scheduled for colposcopy clinic based on screening with abnormal pap smear or have repeat colposcopy indicated for specific clinical indications, based off of American Society of Cosposcopy and Cytology.
  • Subjects are women.

Exclusion criteria

  • Pregnancy.
  • Males (males do not have a cervix and thus cannot undergo colposcopy).

Trial design

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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