Phase I/IIa clinical trial of PDT for cervical intra-epithelial neoplasia using talaporfin sodium and PD laser.

Phase I/IIa clinical trial of PDT for cervical intra-epithelial neoplasia using talaporfin sodium and PD laser. - Phase I/IIa clinical trial of PDT for cervical intra-epithelial neoplasia using talaporfin sodium and PD laser.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000022113

Enrollment

Registered

2016-04-28

Start date

2016-04-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cervical intra-epithelial neoplasia

Interventions

Laser irradiation 4-6 hours after intravenous administration of talaporfin sodium.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Age > 20 2. CIN2 or CIN3 confirmed by histology 3. PS:0 or 1 4. WBC >4,000/mm3 Hb > 10.0g/dL PLT > 100,000/mm3 AST, ALT < 72U/L T.Bil > 2.0mg/dL BUN < 22mg/dL Serum Creatinin < 1.1mg/dL 5. Case not hoping conization for CIN 6. Case who can admit two weeks in the hospital 7. Case with informed consent

Exclusion criteria

Exclusion criteria: 1. Case with glandular dysplasia, AIS or SCC 2. UCF(Unsatisfactory Colposcopic Findings) 3. Case with double cancer 4. UNcontrollable heart, respiratory, liver or kidney disease 5. Case with the past history of conization or PDT for CIN 6. Case with photosensitivity in the past or taking drugs associated with photosensitivity 7. Case with porfirin disease 8. Case with pregnancy or lactation 9. Case under the other clinical trials 10. Case with inadeqate condition for trial

Design outcomes

Primary

Measure	Time frame
Dose Limiting Toxicity for Laser irradiation	—

Secondary

Measure	Time frame
1.Response Rate 12 weeks after PDT 2.Adverse Event after PDT	—

Countries

Japan

Contacts

Public ContactMasaru Sakamoto

Sasaki Foundation Kyoundo Hospital Dept. of Gynecology

m-sakamoto@po.kyoundo.jp03-3292-2051

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026