Clinical trial · Observational
Molecular Imaging for Detection of Cervical Intraepithelial Neoplasia
A Feasibility Study of Molecular Imaging for Detection of Cervical Intraepithelial Neoplasia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Loop Electrosurgical Excision Procedure (LEEP) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 1
- description
- Patients with cervical cancer scheduled to be treated with the LEEP procedure.
- interventionNames
- Procedure: Loop Electrosurgical Excision Procedure (LEEP)
Primary outcomes (1)
- measure
- To learn if a new type of contrast agent (a dye used in certain types of scans and microscope studies) can be used to detect cervical cancer and precancerous lesions better than standard contrast agents.
- timeFrame
- 4 Years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients who are 18 years of age or older. 2. Patients who are not pregnant. 3. Patients who are not HIV positive. 4. Patients who are scheduled to be treated for SIL with LEEP. Exclusion Criteria: 1. Patients who are younger than 18 years of age. 2. Patients who are pregnant. 3. Patients who are HIV positive.
References
Publications (1)
- BACKGROUNDAaron J, Nitin N, Travis K, Kumar S, Collier T, Park SY, Jose-Yacaman M, Coghlan L, Follen M, Richards-Kortum R, Sokolov K. Plasmon resonance coupling of metal nanoparticles for molecular imaging of carcinogenesis in vivo. J Biomed Opt. 2007 May-Jun;12(3):034007. doi: 10.1117/1.2737351. PMID 17614715