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
  Purpose

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.


Condition Intervention Phase
Recurrent Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Drug: fluorine F 18 fluorothymidine
Procedure: positron emission tomography
Procedure: computed tomography
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Phase II Study of Fluorine-18 3'-Deoxy-3'-Fluorothymidine (F-18-FLT) in Invasive Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 49
Study Start Date: December 2008
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00572728

  Show 27 Study Locations
Sponsors and Collaborators
Investigators
Principal Investigator: Lale Kostakoglu American College of Radiology Imaging Network
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00572728     History of Changes
Obsolete Identifiers: NCT00566293
Other Study ID Numbers: NCI-2009-00266, NCI-2009-00266, HM11081, CDR0000689109, ACRIN 6688, 8029, N01CM27165
Study First Received: December 11, 2007
Last Updated: July 23, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Fluorides
Cariostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on October 21, 2014