NCT00690053

Brief Summary

Non invasive imaging of hypoxia with the aid of PET-scans could help to select the patients having a hypoxic tumour who could be treated with specific anti-hypoxic treatments such as bio-reductive drugs or hypoxic radio-sensitizers. Several 2-nitroimidazoles to which the compound to be tested, HX-4, belongs, labelled with Fluor-18 have already been used in patients. However, bad image quality and unpredictable kinetics limit their use. In extensive pre-clinical models, the combination of HX-4 labelled with Fluor-18 is a promising non-toxic new probe to determine hypoxia.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Last Updated

June 30, 2009

Status Verified

February 1, 2009

Enrollment Period

6 months

First QC Date

June 2, 2008

Last Update Submit

June 29, 2009

Conditions

Cancer

Keywords

ToxicityPETHX-4cancer

Outcome Measures

Primary Outcomes (1)

  • Toxicity (CTCAE 3.0)

    9 months

Secondary Outcomes (1)

  • Image Quality at different time points (Tumour-to-Background Ratio determined by PET-CT scan)

    9 months

Study Arms (1)

1

EXPERIMENTAL
Procedure: Injection of HX-4

Interventions

Injection of HX-4PROCEDURE

In step 1: 1 injection of HX-4 (max.6mCi (222MBq)) In step 2: 1 injection of HX-4 (max.12mCi 444MBq)

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histological or cytological confirmed solid tumour, primary or secondary stage IV and/ or tumours with no curative treatment options.
  • Normal white blood cell count and neutrophils
  • Normal platelet count
  • No anaemia requiring blood transfusion or erythropoietin
  • Adequate hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for the institution; ALT, AST, and alkaline phosphatase ≤ 2.5 x ULN for the institution).
  • Calculated Creatinin clearance at least 60 ml/min
  • No administration of Fluor-18 in the previous 24 hours
  • Capable of complying with study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht Radiation Oncology (MAASTRO clinic)

Maastricht, 6229 ET, Netherlands

Location

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 2, 2008

First Posted

June 4, 2008

Study Start

August 1, 2008

Primary Completion

February 1, 2009

Last Updated

June 30, 2009

Record last verified: 2009-02

Locations

NL(1)