Serial Imaging of the Novel Radiotracer [^18F] FLuorthanatrace ([^18F] FTT) by PET/CTF

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

This phase I trial studies how well fluorine F 18 fluorthanatrace positron emission tomography (PET)/computed tomography (CT) works in patients with solid tumors. Fluorine F 18 fluorthanatrace is a radioactive tracer, a type of imaging agent that is labeled with a radioactive tag and injected into the body to help with imaging scans. PET/CT uses a scanner to make detailed, computerized pictures of areas inside the body. PET/CT with Fluorine F 18 fluorthanatrace may allow more tumor cells to be found in patients with ovarian, fallopian tube, or primary peritoneal cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

History of known or suspected solid tumor.

At least one lesion ≥ 1.0 cm that is seen on standard imaging (e.g. computed tomography [CT], magnetic resonance imaging [MRI], ultrasound, fludeoxyglucose [FDG] PET/CT).

Disqualifiers

Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential < 2 weeks prior to screening as standard of care.

Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.

Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study.

Trial design

Design model

Single group

Treatments tested in this trial

  • Computed Tomography

    Procedure/Surgery

    Undergo FDG PET/CT

  • Computed Tomography

    Procedure/Surgery

    Undergo \[18F\]FTT PET/CT

  • Fludeoxyglucose F-18

    Radiation

    Given IV

  • Fluorine F 18 Fluorthanatrace

    Radiation

    Given IV

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo FDG PET/CT

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo \[18F\]FTT PET/CT

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Treatment (FDG PET/CT, [18F]FTT PET/CT)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Poly (ADP-ribose) polymerase inhibitor (PARP)-1 activity as assessed by fluorine F 18 fluorthanatrace positron emission tomography/computed tomography

Data will be generated for semi-parametric uptake of both tracers by patient and by lesion as well as by PARP activity, and summarized as mean and standard deviation (SD) across patients. For patients for whom tumor tissue is saved, the correlation of uptake values and PARP activity as assayed from biopsy specimens will be measured using the rank correlation (Spearman's rho), and test for significance compared to no correlation.

Time frame
Up to 4 years

Secondary outcomes

1

Incidence of adverse events

Time frame
Up to 4 years
2

BRCA mutation status

To determine any correlation with BRCA status, fluorine F 18 fluorthanatrace (\[18F\]FTT) uptake values (mean and SD) across patient and lesion (summing across lesions) will be summarized, by BRCA status group. Group difference will be tested using t-tests.

Time frame
Up to 4 years
3

PARP-1 activity in tumor tissue samples

Data will be generated for semi-parametric uptake of both tracers by patient and by lesion as well as by PARP activity, and summarized as mean and SD across patients. For patients for whom tumor tissue is saved, the correlation of uptake values and PARP activity as assayed from biopsy specimens will be measured using the rank correlation (Spearman's rho), and test for significance compared to no correlation.

Time frame
Up to 4 years
4

Change in fluorine F 18 fluorthanatrace uptake measures after therapy

Time frame
Baseline up to 4 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator