Printed from Voxsanity (voxsanity.com.au) — NCT01394679 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 3 Lung Cancer Trial, Not Yet Recruiting
NCT01394679
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- People who are male or female and at least 18 years old.
- People who agree to undergo several specific procedures, including a tissue sample of the affected area, a SPECT/CT scan, a baseline DCCT scan, a whole-body bone scan, and a follow-up DCCT scan if needed.
- People who have had a non-surgical biopsy or bronchoscope procedure confirming lung cancer, or who have clinical and CT scan findings consistent with a diagnosis of lung cancer — and whose relevant medical reports can be made available to the study doctor within 15 days of the PET imaging study.
- People who are not currently receiving treatment for lung cancer (surgery, radiation, or chemotherapy), or, if previously treated for lung cancer, whose treatment was fully completed at least 3 months before joining the study.
- People who, if a tissue diagnosis was not done before joining, agree to have one done within 15 days of the PET/CT scan but before any treatment begins, regardless of the PET/CT results.
- People who have been referred for a PET/CT scan based on clinical and CT scan evidence pointing toward a diagnosis of lung cancer.
- People with an ECOG performance status of 2 or lower (a measure of how much a person's illness affects their daily activities — confirm with trial site).
- Women who are postmenopausal (at least 12 months without a natural period, or at least 6 weeks after surgical removal of both ovaries), surgically sterile, or who agree to use effective contraception throughout the study; and men who agree to the same if their female partners could become pregnant.
- People who agree to use one of the following contraception methods: surgical sterilisation (hysterectomy or removal of both ovaries), bilateral tubal ligation performed at least 6 weeks before the study (with documentation), an intrauterine device (IUD) in place for at least 3 months, a double-barrier method (condom and diaphragm) with spermicide for at least 14 days before screening and through the study, a stable hormonal contraceptive (oral, skin patch, vaginal, or implanted/injected) used for at least 3 months before the study and through completion, abstinence, or a single-barrier method for at least 14 days before screening and through completion (for vasectomised men or women whose partners are vasectomised).
- People whose fasting blood sugar level is below 200 mg/dL at the screening visit.
- People who have reported symptoms consistent with a diagnosis of lung cancer.
- People who are physically able to lie still in the same position for approximately 45 minutes, hold their arms overhead for approximately 45 minutes, and tolerate being in a confined space during SPECT/CT and PET/CT imaging.
- People who are able to fast and follow dietary restrictions before the scans, including fasting for at least 6 hours before the injection and eating a high-protein, low-carbohydrate meal as their last meal before imaging (or following the trial site's own standard fasting and diet requirements for PET imaging, which would then also apply to the SPECT imaging).
- People who are able to attend all scheduled appointments within the required time windows: PET/CT imaging within 7 days of qualifying for the study, SPECT/CT imaging 1–15 days after the first imaging visit, with at least 24 hours between the two scans.
- People whose blood test results (including liver enzymes, kidney function, and bilirubin levels) are within acceptable ranges in the investigator's judgement, meaning they do not place the person at undue risk from participating.
- People who are able to understand the study information and provide signed informed consent.
- Women of childbearing potential who have a negative pregnancy test (urine or blood) at screening.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People with any significant safety concerns — based on blood tests, heart tracing (ECG), physical examination, or other findings — that the investigator believes would put them at undue risk.
- People who are currently receiving any cancer treatment, including radiation therapy, surgery, or chemotherapy.
- People who have insulin-dependent diabetes, unless the trial site has an approved glucose management plan in place and the sponsor grants a specific waiver allowing participation (confirm with trial site).
- People whose body weight exceeds the weight limit of the SPECT/CT or PET/CT scanning tables.
- People with a known allergy or sensitivity to the imaging agents used in the study (EC DG or FDG) or to similar compounds, including any of their inactive ingredients.
- People who are known or suspected to be pregnant, currently breastfeeding, or planning a pregnancy (applies to female participants and male participants whose partners may become pregnant).
- People with a clinically significant mental illness, as determined by the investigator.
- People who have taken part in another clinical study or received an experimental treatment within 30 days before the screening visit (though the principal investigator may make exceptions with appropriate documentation).
- People with any condition the investigator believes would prevent them from giving informed consent, following study instructions, or that could affect the study results or put them at undue risk.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Contact this trial
Principal Investigator: Cynthia Phurrough, BS, Consultanat
Phone: 281-288-4643
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Trial details
Status
Not Yet Recruiting
Phase
Phase 3
Sponsor
Cell>Point LLC
Registry
ClinicalTrials.gov
Start date
1 May 2025
Est. completion
1 December 2025
This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Efficacy:Comparison of 99mTc-EcC-DG SPECT/CT images to 18F-FDG PET/CT images of primary lung cancer lesion and metastatic lesions
Can't join this trial?
Data last synced from ClinicalTrials.gov: 17 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.