3'-Deoxy-3'-18F Fluorothymidine PET/CT Scanning in Patients Undergoing Treatment for Stage III Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00572728
First received: December 11, 2007
Last updated: July 23, 2014
Last verified: February 2014

December 11, 2007
July 23, 2014
December 2008
December 2014   (final data collection date for primary outcome measure)
Change in FLT uptake between the baseline (pre-therapy) and the early-therapy imaging studies using pathological complete response as a gold standard [ Time Frame: Baseline to 2 years ] [ Designated as safety issue: No ]
To test if FLT uptake measures have any predictive (discriminating) ability, the Receiver Operating Characteristic (ROC) curve will be estimated and the area under the curve, along with its 95% confidence interval, will be determined.
18F]FLT uptake of the primary tumor in patients with locally advanced breast cancer [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00572728 on ClinicalTrials.gov Archive Site
  • Pathological complete response [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Residual cancer burden [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Regional metastasis to the lymph nodes [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Vital signs, clinical laboratory tests, ECG [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
3'-Deoxy-3'-18F Fluorothymidine PET/CT Scanning in Patients Undergoing Treatment for Stage III Breast Cancer
Phase II Study of Fluorine-18 3'-Deoxy-3'-Fluorothymidine (F-18-FLT) in Invasive Breast Cancer

This phase II trial is studying how well 3'-deoxy-3'-18F fluorothymidine PET/CT scanning works in patients undergoing treatment for stage III breast cancer. Diagnostic procedures, such as 3'-deoxy-3'-(18F) fluorothymidine positron emission tomography (PET)/CT scanning, may help in learning how well chemotherapy works to kill breast cancer cells and help doctors plan the best treatment.

PRIMARY OBJECTIVES:

I. To evaluate the relationship between 3'-deoxy-3'-18F fluorothymidine ([18F]FLT) uptake parameters and pathologic complete response to chemotherapy of the primary tumor in patients with locally advanced breast cancer.

SECONDARY OBJECTIVES:

I. To evaluate the relationship between [18F]FLT uptake parameters and the clinical anatomical (CT) and metabolic (fludeoxyglucose [FDG] PET uptake) response.

II. To compare the utility of [18F]FLT and [18F]FDG uptake parameters for predicting early treatment response (response assessment prior to completion of therapy) in patients with locally advanced breast cancer.

III. To demonstrate correlation between [18F]FLT uptake parameters and tumor proliferation markers in breast cancer.

IV. To continue to monitor for potential safety issues and define any physiologic effects associated with [18F]FLT administration.

OUTLINE: This is a multicenter study.

On day 1, patients undergo 3'-deoxy-3'-(18F) fluorothymidine ( [18F]FLT) injection and immediately dynamic regional positron emission tomography (PET)/CT imaging for 60 minutes, followed by a static whole body image over approximately 30 minutes. A second static whole body image is taken at 120 minutes post [18F]FLT injection.

On day 2, patients undergo[18F]FDG injection and PET/CT imaging 1 hour after injection. An additional regional PET/CT image including the primary tumor in the field of view is performed beginning at 2 hours after the injection of [18F]FDG.

Patients undergo three 2-day imaging sessions at baseline before neoadjuvant chemotherapy, mid-neoadjuvant chemotherapy, and post-neoadjuvant chemotherapy before surgery. At the beginning and end of each imaging session, patients complete a questionnaire indicating any appearance or change in signs and symptoms.

After completion of neoadjuvant chemotherapy, patients undergo surgical resection of residual tumor as planned.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Recurrent Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Drug: fluorine F 18 fluorothymidine
    Undergo fluorine F 18 fluorothymidine PET/CT
    Other Names:
    • 18F-FLT
    • 3'-deoxy-3'-[18F]fluorothymidine
    • fluorothymidine F-18
  • Procedure: positron emission tomography
    Undergo fluorine F 18 fluorothymidine PET/CT
    Other Names:
    • FDG-PET
    • PET
    • PET scan
    • tomography, emission computed
  • Procedure: computed tomography
    Undergo fluorine F 18 fluorothymidine PET/CT
    Other Name: tomography, computed
  • Other: laboratory biomarker analysis
    Correlative studies
Experimental: Fluorine F 18 fluorothymidine PET/CT

On day 1, patients undergo 3'-deoxy-3'-(18F) fluorothymidine ( [18F]FLT) injection and immediately dynamic regional positron emission tomography (PET)/CT imaging for 60 minutes, followed by a static whole body image over approximately 30 minutes. A second static whole body image is taken at 120 minutes post [18F]FLT injection.

On day 2, patients undergo[18F]FDG injection and PET/CT imaging 1 hour after injection. An additional regional PET/CT image including the primary tumor in the field of view is performed beginning at 2 hours after the injection of [18F]FDG.

Patients undergo three 2-day imaging sessions at baseline before neoadjuvant chemotherapy, mid-neoadjuvant chemotherapy, and post-neoadjuvant chemotherapy before surgery. At the beginning and end of each imaging session, patients complete a questionnaire indicating any appearance or change in signs and symptoms.

Interventions:
  • Drug: fluorine F 18 fluorothymidine
  • Procedure: positron emission tomography
  • Procedure: computed tomography
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
49
Not Provided
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pathologically confirmed breast cancer
  • Female patients must meet 1 of the following criteria:

    • Postmenopausal for a minimum of one year
    • Surgically sterile
    • not pregnant, confirmed by β-HCG blood test and willing to use adequate contraception during study participation
  • Tumor size > 2 cm measured by imaging or estimated by physical exam
  • Candidate for primary systemic (neoadjuvant) therapy and for surgical resection of residual primary tumor following completion of neoadjuvant therapy
  • WBC >= 3,000/microL
  • Total bilirubin normal
  • AST/ALT =< 2.5 x upper limit of normal
  • Creatinine normal or creatinine clearance >= 60 mL/min
  • Able to lie still for 1.5 hours
  • No obvious contraindications for primary chemotherapy with docetaxel, doxorubicin hydrochloride, or cyclophosphamide
  • Platelet count >= 100,000/microL
  • No previous treatment (e.g., chemotherapy, radiotherapy, or surgery) that involved the breast
  • Absolute neutrophil count >= 1,500/microL

Exclusion Criteria:

  • Not nursing
  • Must be medically stable
  • No uncontrolled intercurrent illness including, but not limited to, any of the following:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Psychiatric illness/social situations that would limit compliance with study requirements
  • No condition requiring anesthesia for positron emission tomography (PET) scanning
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to 3'-deoxy-3'-18F fluorothymidine
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00572728
NCI-2009-00266, NCI-2009-00266, HM11081, CDR0000689109, ACRIN 6688, 8029, N01CM27165
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Lale Kostakoglu American College of Radiology Imaging Network
National Cancer Institute (NCI)
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP