A Pilot, Exploratory, Non-Randomized Study of PET/CT With the Investigational Agent [18F] Fluciclatide to Correlate With Response to Anti-Cancer Therapy

NCT02193672 | Withdrawn Phase 1

• 1 other identifier: 2013-0591
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical research study is to find out if using the tracer (liquid used in imaging scans) \[18F\]fluciclatide in positron emission tomography / computed tomography (PET/CT) scans will help researchers learn more quickly if the disease is responding to treatment.

Conditions

Advanced Cancers

Keywords

Advanced cancers; PET/CT; Positron emission tomography / computed tomography; [18F]Fluciclatide; Chemotherapy; Phone calls

Outcome Measures

Primary Outcomes (1)

• Change in Tumor Uptake

  Primary efficacy endpoint is change in tumor uptake of investigational agent \[18F\]Fluciclatide, as measured by standardized uptake value (SUVFluciclatide) from before treatment to after one cycle of treatment but before the second cycle starts. This determined from investigational agent \[18F\]Fluciclatide PET scans. Changes in SUVFluciclatide compared to standard tumor's response measured after completion of 2 cycles of treatment as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) as well as tumor size change as a continuous variable measured by the standard CT or PET/CT scans. Tumor size can also be measured by the WHO two-dimensional measurement in addition to the Response Evaluation Criteria in Solid Tumors (RECIST), one-dimensional measurement. Changes in SUVFluciclatide after one cycle also compared to tumor volume and tumor size as continuous variables after two cycles.

  After 2, four week chemotherapy cycles

Study Arms (1)

PET/CT + [18F]Fluciclatide

EXPERIMENTAL

At baseline: Participants have PET/CT imaging within 7 days prior to initiation of chemotherapy treatment. Participants monitored at 24 hours post scan via telephone. On treatment: Participants have PET/CT imaging at end of the first cycle and prior to the initiation of the second cycle of chemotherapy. Participants assessed at 24 hours post scan via telephone call. Baseline and on treatment PET/CT imaging performed with agent \[18F\] Fluciclatide.

Drug: [18F] Fluciclatide; Procedure: PET/CT Scan; Behavioral: Phone Calls

Interventions

[18F] Fluciclatide DRUG

\[18F\] Fluciclatide given by vein before PET/CT scan.

PET/CT + [18F]Fluciclatide

PET/CT Scan PROCEDURE

PET/CT scan performed at treatment baseline visit, and about 1 week before first cycle of chemotherapy. Then, a PET/CT scan performed at end of first cycle of chemotherapy.

Also known as: Positron emission tomography / computed tomography

PET/CT + [18F]Fluciclatide

Phone Calls BEHAVIORAL

Phone call to participants by study staff about 24 hours after each PET/CT is performed.

PET/CT + [18F]Fluciclatide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is \>/= 18 years and male or female of any race/ethnicity.
• Patient or patient's legally authorized representative provides written informed consent and is willing to comply with protocol requirements.
• Patient must be scheduled to receive an anti-VEGF inhibitor (bevacizumab, sorafenib, sunitinib, other), mTOR inhibitor (temsirolimus, everolimus, other), or other molecules with antiangiogenic properties including taxol as anti-cancer therapy.
• Patient must have normal hepatic and renal function defined as: 1) AST (SGOT)/ALT (SGPT) \</=3 x institutional upper limit of normal and 2) serum creatinine \</= 2x institutional upper limit of normal.
• Platelet count of \> 75 x 10\^3/μL
• Patients may participate in clinical trials in the Phase I program.
• Patients with any solid tumor type.

You may not qualify if:

• Patient is not capable of complying with study procedures.
• Female patient is pregnant or nursing; exclude the possibility of pregnancy by one of the following: 1) Confirming in medical history that the patient is postmenopausal defined as 12 consecutive months of amenorrhea, or surgically sterile, 2) Confirming the patient is using one of the following methods of birth control for a minimum of one month prior to entry into this study: Intrauterine device (IUD), oral contraceptives, Depo-Provera, or Norplant, 3) Confirming a negative urine dipstick test taken the morning of receiving the investigational agent \[18F\]fluciclatide.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• GE Healthcare: collaborator

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Interventions

AH 111585; Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Apostolia M. Tsimberidou, MD,PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2014
• First Posted: July 18, 2014
• Study Start: August 1, 2014
• Primary Completion: August 1, 2020
• Last Updated: July 18, 2014

Record last verified: 2014-07