Clinical trial NCT00847509: A Multi - Center Study Of PET Imaging With [F-18] FLT & [F-18] FDG in Cancer Patients for Treatment Evaluation
Official title: A Phase II/III, Open Label, Non-Randomized, Multi - Center Study Of Positron Emission Tomography (PET) Imaging With [F-18] FLT Compared to [F-18] FDG in Cancer Patients for Treatment Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Siemens Molecular Imaging
Sponsor class: INDUSTRY
First posted: 2009-02-19
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: [F-18]FLT PET Scan for Early Assessment of Tumor Response to Radiation or Chemoradiotherapy Compared to [F-18] FDG PET Scan
timeFrame: 3-5 weeks after the start of radiation or chemo radio therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital
state: California
city: Houston
country: United States
facility: Excel Diagnostics Imaging Clinics
state: Texas
Study officials:
affiliation: Excel Diagnostics Imaging Clinics
name: Ebrahim S Delpassand, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hoag Memorial Hospital, Newport Beach, CA
name: Michael Brandt-Zawadzki, MD
role: PRINCIPAL_INVESTIGATOR
References: