Clinical trial · Interventional

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

NCT02193672CI-TRIAL-00015131withdrawnPhase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Advanced Cancers	Malignant Neoplasm	CURATED_BROADER	0.78

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
[18F] Fluciclatide	Drug	—	UNRESOLVED
PET/CT Scan	Procedure	—	UNRESOLVED
Phone Calls	Behavioral	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
PET/CT + [18F]Fluciclatide
description
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.
interventionNames
1. Drug: [18F] Fluciclatide
2. Procedure: PET/CT Scan
3. Behavioral: Phone Calls

Primary outcomes (1)

measure
Change in Tumor Uptake
timeFrame
After 2, four week chemotherapy cycles
description
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.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

1. Patient is \>/= 18 years and male or female of any race/ethnicity.
2. Patient or patient's legally authorized representative provides written informed consent and is willing to comply with protocol requirements.
3. 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.
4. 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.
5. Platelet count of \> 75 x 10\^3/μL
6. Patients may participate in clinical trials in the Phase I program.
7. Patients with any solid tumor type.

Exclusion Criteria:

1. Patient is not capable of complying with study procedures.
2. 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.

References

Publications (0)

Data not yet available

No reference posted for this study.