A Multi - Center Study Of PET Imaging With [F-18] FLT & [F-18] FDG in Cancer Patients for Treatment Evaluation

NCT ID: NCT00847509

Last Updated: 2013-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2010-09-30

Brief Summary

Approximately 60 patients will be enrolled with highly suspected lung cancer, or head and neck cancer. The patients must also be starting radiotherapy or a chemoradiotherapy regimen (except with 5-fluorouracil). The patients will undergo 3 visits. One screening, one pre therapy PET/CT imaging visit, and one (3-5 weeks after the start of therapy) post PET/CT imaging visit. This study will evaluate the FLT and FDG images for tumor proliferation rates for early assessment of tumor response to radiation or chemo-radiation combo.

Detailed Description

PHASE: II/III

OBJECTIVES:

Primary: To investigate the clinical value of serial quantitative [F-18] FLT positron image assessment of tumor proliferation rates for early assessment of tumor response to radiation or chemoradiotherapy regimens (except with 5-fluorouracil) in comparison to serial quantitative [F-18] FDG images

Secondary: To gain additional clinical information and experience with [F-18]FLT to guide the design of a future, pivotal, Phase III trial where changes in tumor proliferation from pre-treatment baseline values can be used as a early indicator of response to therapy regimens.

DESIGN: Open label, nonrandomized, uncontrolled, single group assignment

DURATION: Pre treatment [F-18] FLT PET scan following a clinical [F-18] FDG PET scan followed by post treatment [F-18] FLT PET scan and a post treatment, clinical [F-18] FDG PET scan at 4 weeks (±1 week) to monitor radiotherapy or chemoradiotherapy.

PROCEDURES: Informed consent, collection of demographic information, medical history, physical examinations, vital signs, 12-lead ECGs, concomitant medication collection, monitor adverse events, pre treatment [F-18] FLT PET scan and post treatment [F-18] FLT PET scan

SUBJECTS: Approximately 60 patients will be enrolled with confirmed lung cancer, or head and neck cancer. The patients must also be starting radiotherapy or a chemoradiotherapy regimen (except with 5-fluorouracil) to be eligible. This allows for approximately 40 evaluable patients to complete this study at approximately four to eight sites and conducted in the United States.

Conditions

Lung Cancer; Head and Neck Cancer

Keywords

lung cancer; head and neck cancer; radiotherapy; chemoradiotherapy; radiation; chemoradiation; FLT; [F-18]FLT; FDG; [F-18]FDG

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

FLT PET scan

Open label, nonrandomized, uncontrolled, single group assignment, multi-center clinical trial to evaluate \[F-18\] FLT as a PET imaging tool in cancer patients clinically scheduled for treatment with radiation or radiation - chemotherapy. Standard \[F-18\] FDG PET will be the active comparator.

Group Type: EXPERIMENTAL

[F-18]FLT

Intervention Type: DRUG

The individual doses of \[F-18\]FLT contain a maximum of 10 mCi. The single IP dose is administered to the study subject approximately 30 to 60 minutes prior to the start of PET imaging.

Interventions

[F-18]FLT

The individual doses of \[F-18\]FLT contain a maximum of 10 mCi. The single IP dose is administered to the study subject approximately 30 to 60 minutes prior to the start of PET imaging.

Intervention Type: DRUG

Other Intervention Names

[F-18] FLT; FLT

Eligibility Criteria

Inclusion Criteria

• Patient provides written Informed Consent and is willing to comply with protocol requirements
• Patient is at least 18 years of age on the day of dosing (male or female of any race or ethnicity)
• Patient is capable of lying still in the PET scanner for the protocol required time frame(s)
• Patient has a diagnosis of one of the following malignancies using the TNM Staging System:
• Lung cancer (T3 grade up, node positive, but no metastatic disease)
• Head and neck cancer (T3 grade up, node positive, but no metastatic disease)
• Patient has undergone a comparative, diagnostic procedure with lesion(s) visible, other than ultrasound, that includes, but is not limited to computed tomography (CT), magnetic resonance imaging (MRI), nuclear medicine imaging, endoscopy, laparoscopy, standard abdominal x-ray, biopsy and/or surgery for one of the above mentioned areas
• Patient is scheduled to start radiotherapy or a chemoradiotherapy regimen for curative intent
• As a part of his/her standard radiotherapy or chemoradiotherapy regimen, patient is scheduled to have clinical [F-18]FDG PET scans pre treatment and post treatment (at about 4 weeks (±1 week) after the start of therapy)
• Patient is scheduled to have the investigational, pre treatment [F-18] FLT PET scan recommended to be within ± 2 days of the clinical, pre treatment [F-18] FDG PET scan
• Patient has not received or intends to receive 5-fluorouracil (chemotherapeutic agent)
• Patient has a score of greater than or equal to (>/=) 60% on the Karnofsky Performance Status Scale

Exclusion Criteria

• Patient is a pregnant or lactating female. Exclude the possibility of pregnancy:
• by testing on site at the institution (serum or urine βHCG) within 48 hours prior to the start of each investigational product administration
• by surgical history (eg, tubal ligation or hysterectomy)
• by patient's history of being post menopausal with a minimum 1 year without menses
• Patient is undergoing treatment with palliative intent
• Patient has received an investigational compound and/or medical device within 14 days before admission into this study
• Patient has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations
• Patient is determined by the Investigator that he/she is clinically unsuitable for the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Siemens Molecular Imaging

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ebrahim S Delpassand, MD

Role: PRINCIPAL_INVESTIGATOR

Excel Diagnostics Imaging Clinics

Michael Brandt-Zawadzki, MD

Role: PRINCIPAL_INVESTIGATOR

Hoag Memorial Hospital, Newport Beach, CA

Locations

Hoag Memorial Hospital

Newport Beach, California, United States

Excel Diagnostics Imaging Clinics

Houston, Texas, United States

Countries

United States

Other Identifiers

FLT101

Identifier Type: -

Identifier Source: org_study_id