MDACC Study Summary 2009-0073

Study Summary
No. 2009-0073:.......Breast; Lung; Prostate......Homer Macapinlac......Nuclear Medicine

Study Summary Title



Study Summary Number:	2009-0073

Study Title:	18F-Fluoride PET/CT versus 99mTc-MDP Scanning for Detecting Bone Metastases: A Randomized, Multi-Center Trial to Compare Two Bone Imaging Techniques

Physician

New Patient Referral



Name:	Homer Macapinlac	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Nuclear Medicine	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-7126 Contact us about clinical trials

General Information



Disease Group:	Breast Lung Prostate	Supported By:	Academy of Molecular Imaging (AMI)

Phase of Study:	Phase III	Return Visit:	n/a

Treatment Agents:	18F-Flourine	Home Care:	n/a

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	n/a


Description/ Intervention:	The goal of this clinical research study is to compare a positron emission tomography/computed tomography (PET/CT) scan using an experimental "imaging solution", called radioactive fluoride (F18 Fluoride), to a standard bone scan to learn if the cancer has spread to the bones.

Study Objectives / Outcomes

The primary objective is to compare the diagnostic performance of [18F]fluoride positron emission tomography/computed tomography (PET/CT) to that of conventional bone scanning with 99mTc-Methyl diphosphate (99mTc-MDP) for detecting cancer that has spread to the bone (bone metastasis). The hypothesis is that PET/CT scanning will be superior to conventional bone scanning for the detection of bone metastases. Our primary measure will be differences in the area under the curves (AUC) of the receiver operating characteristic (ROC) curves we will generate from the interpretations of each technology. It is expected that the 99mTc-MDP scanning will perform at a level of approximately 0.70 area under the receiver operating characteristic curve (ROC) as compared to 0.80 for [18F]fluoride PET/CT scanning.

Secondary objectives are:
• To assess differences in sensitivity and specificity in detecting bone metastases between the two modalities.
• To conduct subgroup analyses of 18F-PET/CT and conventional bone scanning performance based on such variables as cancer type and patient gender.
• To determine the number of equivocal and diagnostic tests resulting from the two modalities.
• To determine the impact of 99mTc-MDP and 18F-fluoride imaging on patient management.
• To report and analyze the number of adverse events that are reported during and post-administration period of both study drugs.
• To assess how the blinded independent core lab interpretations of 18F-PET/CT and conventional bone scanning differ from the readings of on-site readers
providing interpretations for clinical care.

Study Status Information



Study Activation / Registration Date:	07/27/2009

IRB Review and Approval Date:	06/17/2009

Study Type:	Phase Iii

Recruitment Status:	Closed

Projected Accrual:	550

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patient is >/= 18 years old at the time of the drug administration (Patient is male or female of any race / ethnicity.)

2) Patient or patient's legally acceptable representative cognitively provides written informed consent

3) Patient without known bone metastases will be included. They will have >/= stage 3 breast cancer, >/= stage 3 lung cancer, or >/= stage 2 prostate cancer (and/or prostate-specific antigen (PSA) >10 micrograms/L). Patients without known bone metastases who have recurrent breast, lung or prostate cancer can also be included

4) Patient who is scheduled to undergo a conventional bone scan

5) Patient is capable of complying with study procedures

6) Patient is able to remain still for duration of imaging procedure (about one hour)

7) Patient may have had a prior PET or PET/CT scan for staging/restaging

Exclusion Criteria:

1) Patient is < 18 years old at the time of the drug administration

2) Patient is pregnant or nursing; For females of child bearing potential, test on site at the institution (urine or serum beta-human chorionic gonadotropin [�hCG]) within 24 hours prior to the start of investigational product administration; Pregnancy is ruled out by surgical history (e.g., tubal ligation or hysterectomy); or confirming the patient is post menopausal, with a minimum 1 year without menses

3) Patient has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data

4) Patient has known bone metastases

5) Patient has previously received [18F]NaF in the last thirty days

Links

Registration Number: NCT00882609
Study Information on Clinical Trials Registry (clinicaltrials.gov)