Phase 1 Colorectal Cancer Trial, Recruiting NCT05556473 Sponsor: Barbara Ann Karmanos Cancer Institute Condition: Colorectal Cancer
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Phase 1 Colorectal Cancer Trial, Recruiting

NCT05556473
Recruiting Phase 1

Who may 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 might be able to join this trial:

  • You must be 18 years old or older.
  • The tumor being studied must be at least 1 cm (about half an inch) across, as seen on a scan.
  • You must be able to lie still in a PET/CT scanner for at least 70 minutes.
  • You must have had a recent scan (such as an MRI or CT) that shows the tumor, so it can be compared to the new PET/CT scan.
  • You must have had a physical exam within the last 28 days and certain blood tests within the last 14 days before the PET scan.
  • You must be willing to sign a consent form confirming you understand this is a research study.
  • Women who could become pregnant must not currently be pregnant or breastfeeding.

If you have a brain tumor, you also need to meet these criteria:

  • A doctor must have diagnosed, or suspected, a brain tumor based on clinical assessment and MRI scan — this includes tumors that are new, remaining after treatment, or have come back.

If you have a neuroendocrine tumor outside the brain, you also need to meet these criteria:

  • Your neuroendocrine tumor must have been confirmed by a tissue biopsy and be a well-differentiated (slower-growing) type that has spread to other parts of the body.
  • You must be well enough to carry out basic daily activities (confirm with trial site).
  • You may be on certain long-term hormone-like medications (called somatostatin analogs) for more than 3 months, but this is not required.

If you have breast cancer, you also need to meet these criteria:

  • A doctor must have diagnosed breast cancer based on clinical and imaging findings.
  • You must be well enough to carry out basic daily activities (confirm with trial site).

If you have rectal cancer, you also need to meet these criteria:

  • Your colorectal cancer must have been confirmed by a tissue biopsy and must be located in the rectum.
  • You must be well enough to carry out basic daily activities (confirm with trial site).

Who may not be able to join:

  • You are currently pregnant or breastfeeding.

For brain tumor patients:

  • You have severely raised pressure in your skull, uncontrolled seizures, or another urgent condition needing immediate medical treatment.
  • You have had brain tumor surgery or radiation treatment within 1 month before the planned PET scan.

For neuroendocrine tumor patients:

  • You have received any treatment directed at the tumor within the past 3 months in the area to be scanned.
  • You are currently receiving certain targeted drug therapies (such as sunitinib or everolimus) or chemotherapy (such as capecitabine or temozolomide).
  • You have taken a medication called telotristat ethyl within the past month.

For breast cancer patients:

  • You have had surgery on the tumor, or radiation or chemotherapy, within the past month.

For rectal cancer patients:

  • You have active inflammatory bowel disease (such as Crohn's disease or ulcerative colitis) that affects the rectum.

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.
Last synced 20 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Csaba Juhasz, M.D.,Ph.D, Barbara Ann Karmanos Cancer Institute

Phone: 313-966-5136

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Barbara Ann Karmanos Cancer Institute
Registry
ClinicalTrials.gov
Start date
29 September 2022
Est. completion
31 December 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

The percent difference in tracer uptake values between the tumor mass and the background (non-tumor tissue); Correlation between the 1-(2-[18F]fluoroethyl)-L-tryptophan tracer uptake values and the tracer transport rates measured in the same breast tumor tissue.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 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.

View original record on ClinicalTrials.gov