Patients with suspicion or high risk of neoplasia in the colon
Conditions
Interventions
Product Name: Lumacan-Formulierung A (Miglyol formulation)
Product Code: P-1206
Pharmaceutical Form: Capsule*
INN or Proposed INN: Hexyl aminolevulinate hydrochloride
CAS Number: 140898-91-5
Current S
Sponsors
Photocure ASA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Female and male subjects with known or strong suspicion of adenoma or carcinoma of the colon after screening of follow-up colonoscopy. • Female and male patients with verified neoplastic lesions. • Written Informed Consent obtained • Age 18 years or above Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Known or suspected Porphyria • Contraindications to colonoscopy • Known allergy to hexaminolevulinate, methyl aminolevulinate or aminolevulinate or a similar compound • Participation in other clinical studies either concurrently or within the last 30 days • Female subjects with childbearing potential (i.e. ovulation, pre-menopausal, not surgically sterile) not willing to use a medically accepted contraceptive regimen while on treatment. • Pregnant or lactating women • Conditions associated with a risk of poor protocol compliance • Vulnerable patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine carcinoma and adenoma lesion true detection rate of HAL fluorescence colonoscopy in patients with known or strong suspicion of neoplasia of the colon.;Secondary Objective: •To determine carcinoma- and adenoma lesion false detection rate of HAL fluorescence colonoscopy. •To compare carcinoma- and adenoma lesion true detection rates and the false detection rates of fluorescence and standard white light colonoscopy. •To further characterise the safety profile of HAL fluorescence colonoscopy ;Primary end point(s): Primary endpoint: To determine carcinoma- and adenoma lesion true detection rate of HAL fluorescence colonoscopy in patients with known or strong suspicion of neoplasia in the colon. Secondary endpoints. •To determine carcinoma- and adenoma lesion false detection rate of HAL fluorescence colonoscopy. •To compare carcinoma- and adenoma lesion true detection rates and the false detection rates of fluorescence with standard colonoscopy. •To characterize the safety profile of HAL fluorescence colonoscopy. | — |
Countries
Germany
Outcome results
None listed