Evaluation of Fluciclovine Uptake in Patients With Cervic... | NCT03349463

Studies
Evaluation of Fluciclovine Uptake in Patients With Cervical, Ovarian Epithelial or Endometrial Cancers.

NCT03349463

Sponsor

Bital Savir-Baruch

Status

Unknown status

Last Update Posted

Feb 28, 2020Actual

Enrollment

30Estimated

Phase

Phase 4

Conditions

Cervical Cancer
Endometrial Cancer
Ovarian Epithelial Cancer

Interventions

Fluciclovine F18

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 14, 2018Actual

Primary Completion Date

Dec 2020Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Nov 17, 2017

First Submission Date that Met QC Criteria

Nov 17, 2017

First Posted Date

Nov 21, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2020

Last Update Posted Date

Feb 28, 2020Actual

Name	Class
Blue Earth Diagnostics	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

An important part of staging and deciding the method of treatment is knowing areas of how cancer is involved. Diagnostic imaging is often used to determine the location of the cancer using techniques like nuclear medicine, MRI (magnetic resonance imaging), CT (computerized tomography), and ultrasound. Each technique looks for cancer in different ways and are often used together to make a better determination of the extent of disease.

One of the techniques used in cancer imaging is PET/CT. This technique combines a nuclear medicine study (PET or positron emission tomography) with CT performing both scans at the same time. PET/CT most commonly uses a radioactive sugar (FDG or fluorodeoxyglucose) to detect the cancer. The problem with FDG is that it is excreted by the kidneys and collected in the bladder. Even though the bladder is emptied prior to the scan, the FDG activity present there may interfere with the detection of small areas of cancer involvement in lymph nodes or adjacent areas. It is because of this that PET/CT using FDG is infrequently used in gynecological cancers.

This purpose of this study is to evaluate if 18F-fluciclovine can be used to help determine the extent of gynecological cancers. 18F-fluciclovine (also known as AXUMIN) is a radioactive tracer which has been approved by the FDAFood and Drug Administration (FDA) for use in patients with prostate cancer. 18F-fluciclovine has much less excretion through the kidneys which improves the PET/CT imaging of the pelvis.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
18F-Fluciclovine	Experimental		Drug: Fluciclovine F18

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fluciclovine F18	Drug	All study participants will receive 10 mCi of 18F-Fluciclovine (Axumin) one time administered through injection through the catheter into participant's arm immediately before PET/CT scan.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
18F-Fluciclovine uptake in gynecologic neoplasms	PET/CT imaging	Day 30

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

GYN cancer (ovarian, endometrial, or cervical) was biopsy-proven and/or schedule for subsequent surgery based on clinical presentation (imaging, markers)
Age ≥ 18 years.
Can tolerate 18F-fluciclovine PET/CT exam (can lie on her back for the duration of the scan).
Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

Ongoing systemic therapy for cancer
Systemic therapy for cancer in the past 3 months
Inability to tolerate 18F-fluciclovine PET/CT exam
Pregnant or lactating women

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rachel Ochoa, BA	Contact	708-327-3221		raochoa@luc.edu

Overall Officials

Name	Affiliation	Role
Bital Savir-Baruch, M.D	Nuclear Medicine Assistant Professor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Loyola University Medical Center	Recruiting	Maywood	Illinois	60153	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27178725	Background	Atri M, Zhang Z, Dehdashti F, Lee SI, Ali S, Marques H, Koh WJ, Moore K, Landrum L, Kim JW, DiSilvestro P, Eisenhauer E, Schnell F, Gold M. Utility of PET-CT to evaluate retroperitoneal lymph node metastasis in advanced cervical cancer: Results of ACRIN6671/GOG0233 trial. Gynecol Oncol. 2016 Sep;142(3):413-9. doi: 10.1016/j.ygyno.2016.05.002. Epub 2016 Jul 27.
15590954

ID	Term
D002583	Uterine Cervical Neoplasms
D016889	Endometrial Neoplasms
D000077216	Carcinoma, Ovarian Epithelial

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site