Skip to content

A phase II, open label, non-randomized, multi-center, pilot, efficacy study of [F-18]RGD-K5 positron emission tomography (PET) as a tool to monitor response to an anti-angiogenic drug

A phase II, open label, non-randomized, multi-center, pilot, efficacy study of [F-18]RGD-K5 positron emission tomography (PET) as a tool to monitor response to an anti-angiogenic drug - [F-18]RGD-K5

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON34945
Enrollment
10
Registered
2010-02-22
Start date
2010-03-01
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

colorectal liver metastases

Interventions

None listed

Sponsors

Siemens Molecular Imaging Biomarker Research
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Patient is >18 years and male or female of any race / ethnicity • Patient provides written informed consent and willing to comply with protocol requirements • Patient must be scheduled to receive chemotherapy treatment(s) plus Avastin® for their cancer care; treatment management will be made by treating medical oncologists (According to the package insert for Avastin®, it is administered as an IV infusion every 3 weeks for non-squamous non-small cell lung cancer, and every 2 weeks for metastatic breast cancer, colon or rectum cancer) • Patient will be scheduled to have a clinical [F-18] FDG-PET/CT or diagnostic CT pretreatment, and after the fourth but before the fifth Avastin® treatment

Exclusion criteria

Exclusion criteria: • Patient is not capable of complying with study procedures • Female patient is pregnant or nursing • Patient has a severe hepatic or renal disease as defined by previous medical history or abnormal renal and hepatic functions determined by lab results not within the following ranges, or in the opinion of the Investigator, the values are not acceptable for the patient to be included: o AST (SGOT)/ALT (SGPT)

Design outcomes

Primary

MeasureTime frame
The primary objective for this study is: • To explore the usefulness of [F-18]RGD-K5 PET/CT to predict efficacy or early response to Avastin® (the anti-angiogenesis drug) plus chemotherapy treatment before the full course of treatment is completed

Secondary

MeasureTime frame
The secondary objective for this study is: • To gain experience with [F-18]RGD-K5 PET/CT in order to improve the study design and conduct of future studies

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)