Follow-up Evaluation of Photo-Dynamic Therapy for Pituitary Tumours

Pituitary Neoplasms Clinical Trial

Official title:

Follow-up Evaluation of Photo-Dynamic Therapy for Pituitary Tumours

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02632084
• Other study ID #: NE13/10696
• Status: Completed
• Phase: N/A
• First received: December 10, 2015
• Last updated: December 11, 2015
• Start date: March 2010
• Est. completion date: September 2011

Study information

• Verified date: December 2015
• Source: The Leeds Teaching Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

A study to followup patients that have previously been treated for pituitary tumours with either photodynamic therapy or placebo in a previous trial. The study aims to determine whether photodynamic therapy has any long term effect on tumour size, visual fields or endocrinological function.

Description:

No patients will receive any medical or procedural treatments in this study, since these have been administered in a previous trial. The previous trial participants will be contacted and asked to attend a clinic or to have a telephone interview, where they will answer a questionnaire. They will be assessed clinically for visual fields, as well as undergoing an MRI scan of their head to assess tumour size (unless they have had a scan anyway in the previous 12 months), these tests would ordinarily form part of the routine outpatient workup for patients with pituitary tumours. There is no significant risk to the physical well-being of the patients with any of the methods to be used.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients who were previously included in the initial pituitary PDT trial, in addition to those who were randomised as part of the RCT arm of the study. These patients have already participated in phase I/II trials. Of note, these patients all have pituitary tumours.

Exclusion Criteria:

• Patients who were not included in the above mentioned trials. Patients included in the original trials who have subsequently died (of any cause).

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pituitary Diseases
• Pituitary Neoplasms

Locations

Country	Name	City	State
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
The Leeds Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumour size on MRI scan.		6 months	No