Cervical Cancer Clinical Trial
Official title:
A Feasibility Study of Molecular Imaging for Detection of Cervical Intraepithelial Neoplasia
The hypothesis of this research project is that topical application of the anti-EGFR or
anti-E6/E7 contrast agents followed by optical imaging will yield images that reflect
spatial variations in expression that correlate with the presence of cervical precancer. To
gather feasibility data the investigators will:
1. Obtain cervical specimens from women with high grade squamous intraepithelial lesions
(HGSILs) being treated with the loop electrosurgical excision procedure (LEEP).
2. After Loop Electrosurgical Excision Procedure (LEEP) is performed, obtain low and high
resolution optical images before and after applying contrast agents topically to the
epithelial surface of the tissue for 30 minutes before rinsing.
3. Submit the specimen for histology, and have it sectioned and stained using both H&E and
immunohistochemical staining for EGFR or E6/E7. The images will be reconstructed into a
two dimensional map delineating areas of Cervical Intraepithelial Neoplasia (CIN) and
of EGFR or E6/E7 overexpression. Maps of the pathology will be compared to those
obtained from the intact cervix exposed to the contrast agent.
During your scheduled colposcopy, a sample of tissue will be removed from your cervix using
the loop electrosurgical excision procedure (LEEP). The LEEP is the standard of care
treatment for the precancerous condition on your cervix. The details of the procedure will
be covered in another consent form. Before the LEEP, a photograph will be taken of the
cervix. This photograph will be taken for research purposes, so that researchers will have a
photograph to compare to the images taken with the MDC and Confocal.
The tissue that is removed will be taken to a room where the researchers will use a special
microscope to look at the tissue before and after the new contrast agent is painted on the
surface of the tissue. After the tissue samples are looked at, they will be sent to the lab
for routine tests (as part of your standard of care).
You will require a LEEP whether you participate in this study or not. The tissue removal is
a standard part of the LEEP. The experimental portion of this study is the use of the
contrast agent. Once that portion is complete, the tissue will be tested as per standard of
care. The tissue will not be used for any other research testing.
You will not be told of any of the experimental findings with the contrast agent. However,
your doctor and/or nurse practitioner will be told the results of the routine tests, and
they will give these results to you.
This is an investigational study. The LEEP is considered standard of care and any charges
associated with the LEEP will be the responsibility of you and/or your insurance provider.
Up to 80 women will take part in this multicenter study. Up to 40 will be enrolled at M.D.
Anderson.
;
Observational Model: Case-Only, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06223308 -
A Study Evaluating the Safety and Efficacy of HB0028 in Subjects With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Terminated |
NCT03367871 -
Combination Pembrolizumab, Chemotherapy and Bevacizumab in Patients With Cervical Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT04537156 -
Efficacy, Immunogenicity and Safty Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)
|
Phase 3 | |
| Recruiting |
NCT03668639 -
Safety and Antiemetic Efficacy of Akynzeo Plus Dexamethasone During Radiotherapy and Concomitant Weekly Cisplatin
|
Phase 2/Phase 3 | |
| Active, not recruiting |
NCT04242199 -
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors
|
Phase 1 | |
| Withdrawn |
NCT04806945 -
A Phase III Study to Evaluate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy in Patients With Advanced Cervical Cancer
|
Phase 3 | |
| Active, not recruiting |
NCT04185389 -
Long-Term Follow-Up of HPV FOCAL Participants
|
||
| Withdrawn |
NCT03007771 -
Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia
|
Phase 1 | |
| Completed |
NCT03384511 -
The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies.
|
Phase 4 | |
| Recruiting |
NCT05107674 -
A Study of NX-1607 in Adults With Advanced Malignancies
|
Phase 1 | |
| Completed |
NCT05120167 -
Strategies for Endocervical Canal Investigation in Women With Abnormal Screening Cytology and Negative Colposcopy
|
N/A | |
| Recruiting |
NCT05483491 -
KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer
|
Phase 1 | |
| Recruiting |
NCT05736588 -
Elimisha HPV (Human Papillomavirus)
|
N/A | |
| Completed |
NCT05862844 -
Promise Women Project
|
N/A | |
| Recruiting |
NCT04934982 -
Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IA1 With LVSI, IA2)
|
N/A | |
| Recruiting |
NCT03876860 -
An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis
|
N/A | |
| Completed |
NCT03652077 -
A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies
|
Phase 1 | |
| Completed |
NCT00543543 -
Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001)
|
Phase 3 | |
| Terminated |
NCT04864782 -
QL1604 Plus Chemotherapy in Subjects With Stage IVB, Recurrent, or Metastatic Cervical Cancer
|
Phase 2/Phase 3 | |
| Recruiting |
NCT04226313 -
Self-sampling for Non-attenders to Cervical Cancer Screening
|
N/A |